Trial summary

The aim of the Noah Medical FRONTIER Study is to assess the safety, efficacy and feasibility of the Galaxy Robotic Bronchoscopy System for the sampling of small peripheral pulmonary (lung) nodules that are suspected of being cancerous.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have a moderate to high risk of lung cancer based on clinical, demographic, and imaging information, you have had a lung CT scan within 30 days of the pending bronchoscopy procedure and your specialist has indicated that your nodules are of an appropriate size and shape for biopsy via bronchoscopy.

Study details
All participants who choose to enrol in this study will undergo pre-operative and post-operative procedures in line with the standard method of lung nodule biopsy. Prior to your procedure this involves having a physical examination, medical history and CT scan of the Chest performed. Following your procedure you will be monitored for any side effects of the biopsy process and also have a Chest X-Ray to assess your lungs and the area that has been biopsied. Participants in this study will then have one of their nodules biospied using the Noah Medical Galaxy Robotic Bronchoscopy System. The Galaxy system reads the pre-operative CT scan and uses this information to locate a suspicious nodule for biopsy. If the robotic system is unable to locate and reach the pulmonary nodule, standard of care methods using probes inserted via a conventional bronchoscope will be used to sample the pulmonary nodule. Participants who chose to enrol will be followed at 24-28 hours post-operation and then 7 days following their procedure. If a diagnosis is unable to be made at this time participants will be required to be followed up at 6 months to check on the progress of their pulmonary nodule.

It is hoped this research will determine whether use of a novel robotic biopsy system is safe and feasible for use in patients with a moderate to high risk of lung cancer. If the robotic system is found to be safe and effective for biopsy of suspected cancer nodules, it may be used more widely for the treatment of future lung cancer patients

Broad Health ConditionPeripheral Pulmonary Nodules

Specific Health ConditionRespiratory
Other respiratory disorders / diseases
Cancer
Lung - Non small cell

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Macquarie University Hospital - Macquarie Park

Postcode
2109 - Macquarie Park

Anticipated date of last participant enrolment30/06/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Age greater than or equal to 18 years of age
Patients with a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information, determined by the Interventional Pulmonary Nodule MDT based on the site’s standard of care
Solid peripheral pulmonary nodules (PPNs) sized 1 to 3 cm measured as the largest dimension
Pre-procedural CT is conducted within 30 days of the bronchoscopy procedure
Peripheral Pulmonary Nodules that are accessible bronchoscopically on planning CT reconstruction based on MDT discussion
Informed consent properly obtained per local regulations

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Known pregnancy or breastfeeding
Patients with a subsolid nodule (pure or partly solid ground-glass nodules) on pre-procedural chest CT
Uncontrolled coagulopathy or bleeding disorders
Ongoing systemic infection
Past history of lobectomy
Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days.
Moderate-to-severe hypoxia, hypoxemia, or hypercarbia
Patients with implanted pacemakers or defibrillators
Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
Patients who are unable to provide written informed consent to participate in the study

Trial summary

This study aims to test if it is practical to conduct a one-off multi-disciplinary team (MDT) consultation for patients with advanced non-small cell lung cancer, focussing on survivorship care needs.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older, have advanced non-small cell lung cancer, and have been receiving your current cancer treatment for at least 6 months without the disease getting worse on scans.

Study details
All patients who enrol in this study will be invited to participate in a single, 30-minute, multi-disciplinary team (MDT) meeting via a secure, online video-conferencing platform. The meeting will focus on any unmet needs and concerns the participating patient may have related to survivorship, with discussion led by a lung cancer specialist nurse from the hospital. The MDT will include the patient (+/- a family member), hospital doctor, allied health professional, and a member of the patient’s primary care team (ideally the patient’s GP). Prior to the MDT meeting, all patients will be asked to complete a survey to identify survivorship concerns in order to guide the MDT discussion, and they will receive a 15-minute call by a member of the study team prior to the MDT meeting. The patient’s GP will also be asked to complete a 5-minute questionnaire prior to the MDT. After the MDT meeting a survivorship care plan will be produced summarising the discussion at the MDT meeting, and a copy made available to the patient, the patient’s GP and placed in the patient’s hospital record.

Three months after the MDT meeting, participating patients and GPs will be asked to complete a short follow-up questionnaire about how acceptable the MDT meeting process was. Later on (4-4.5 months post participating in the MDT meeting) some patients and their GPs will also be invited to participate in an interview to discuss their impressions of participating in the MDT meeting.

Rationale
It is hoped that this study will show that a MDT consultation is both feasible and acceptable to patients, hospital and community-based health-care providers, and enable further implementation of these consultations to improve the survivorship care for patients living with advanced non-small cell lung cancer.

Broad Health Conditionmetastatic non-small cell lung cancer
metastatic cancer survivorship

Specific Health ConditionCancer
Lung - Non small cell

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Anticipated date of first participant enrolment19/09/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1. Histologically confirmed unresectable locally advanced or metastatic NSCLC 
2. Age >/= 18 years
3. Able to understand, speak and read in English without the use of an interpreter
4. >/= 6 months post initiation of current line of systemic therapy without radiological evidence of disease progression (stable disease, complete or partial response on CT performed within 3 months prior to enrolment; or complete or partial metabolic response, or stable disease on PET)
5. Able to give informed written consent
6. Access to computer with internet connection

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Psychiatric comorbidity that would preclude participation in the study procedures
2. A diagnosis of unresectable NSCLC that is being managed with ‘definitive’ or ‘curative’ intent (eg patients with stage III NSCLC undergoing concurrent chemoradiotherapy followed by consolidation durvalumab)

Trial summary

Lung cancer is the largest cause of cancer related death in the world. Low dose computed tomography (LDCT) is a scan that reduces deaths from lung cancer by detecting early disease, which is currently being investigated as a screening program for current or former smokers as part of the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital. Physical activity is a potentially modifiable risk factor for the development of lung cancer. Therefore, the purpose of this study is to see if it is feasible to implement an exercise program as part of lung cancer screening to modify an individual’s risk profile.

Who is it for?
You may be eligible for this study if you are aged 55 to 80 years, are already enrolled in the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital (NCT02871856), and are a current or former smoker estimated to be at a high risk of lung cancer.

Study details
Participants will be randomised (i.e. allocated by chance) to either the intervention group, which will receive a home-based exercise program, or to a control group that will not receive the exercise program. The home-based exercise program will involve an 8 week unsupervised program consisting of education, aerobic exercise, and resistance training, with weekly progress reviews and goal setting. Weekly progress reviews and goal settings involves a telehealth or telephone consultation of up to 30 minutes per week. Targets for aerobic exercise over the week will range up to 300 minutes per week divided over multiple sessions. Resistance training will be up to two 30 minute sessions per week.   Participants allocated to the exercise program will also receive written materials describing Australia’s physical activity and sedentary behaviour guidelines, and will continue to receive usual care, defined as their current medical, nursing and allied health support. Participants in the control group will receive usual care and access to the written materials only. 9 weeks after commencing the intervention or control treatments, all participants will be assessed for feasibility of the intervention by adherence to exercise sessions, as well as for safety of the intervention by number of adverse events occurring during or within 60 minutes following the intervention. Participants will also be assessed for any changes in known contributors to lung cancer risk, including physical activity levels, exercise capacity, muscle strength, body composition, and overall health and wellbeing at 9 weeks and 6 months after commencing the intervention or control treatments.

It is hoped that this study may show that the addition of a home-based exercise program to lung cancer screening is feasible, safe, and is able to improve the lung cancer risk profile of current or former smokers.

Broad Health Conditionlung cancer screening

Specific Health ConditionCancer
Lung - Non small cell
Cancer
Lung - Small cell

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Royal Melbourne Hospital - City campus - Parkville

Postcode
3050 - Parkville

Anticipated date of last participant enrolment30/11/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

People already enrolled in the International Lung Screening Trial (ILST, NCT02871856. ) at the Royal Melbourne Hospital.  

To be eligible for the program patients must be:
-	Women or men age 55 to 80 years at the time of recruitment to the ILST.
-	Current or former smokers. A former smoker is defined as one who has stopped smoking for one or more years.
-	An estimated 6-year lung cancer risk of greater than or equal to 1.51% based on the PLCOm2012 risk prediction model or greater than or equal to 30 pack-years smoking history (pack-year is defined as number of pack of cigarettes smoked per day multiply by the number of years smoked. If a participant stopped smoking for 6 months or more and then restarted smoking again, the time will be subtracted from the total duration of smoking in 0.5 year increments)
-	ECOG performance status 0 or 1  

Capable of providing, informed consent for screening procedures (low dose spiral CT)

Minimum age55 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Unable to ambulate 100m independently +/- aid
Unable to safety complete the home-based components of the intervention.
Co-morbidity or medical status preventing exercise, for example acute uncontrolled cardiovascular or respiratory issues
Have a diagnosis of lung cancer

Trial summary

The purpose of the study is to test the effectiveness of a new treatment combination for patients with non-small cell lung cancer (NSCLC) whose tumour has a specific type of gene mutation called KRAS G12C. This mutation is believed to cause the tumour to grow and spread.

Who is it for?
You may be eligible for this study if you are aged 18 years and older, with either:
a) newly diagnosed, treatment naïve metastatic (Stage IV) non-squamous NSCLC, or
b) recurrent non-squamous NSCLC with no disease progression for at least 6 months following prior curative lung surgery and (neo)adjuvant chemotherapy, or prior curative concurrent chemoradiotherapy and immunotherapy maintenance, for non-resectable stage III cancer.

Study details
The new drug, sotorasib, is a tablet treatment which is targeted against the KRAS G12C gene mutation. Early results show that sotorasib is moderately active when given alone. The effectiveness of sotorasib might be increased when given in combination with other anti-cancer drugs. This study will investigate whether sotorasib used in combination with two chemotherapy drugs (called carboplatin and pemetrexed) and bevacizumab (which improves anti-cancer drug delivery), can result in better outcomes. The combination of carboplatin-pemetrexed-bevacizumab is a proven treatment for NSCLC.

Broad Health Conditionadvanced non-squamous non-small cell lung cancer with KRAS G12C mutation

Specific Health ConditionCancer
Lung - Non small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC

Hospital
GenesisCare – North Shore - St Leonards

Hospital
The Northern Beaches Hospital - Frenchs Forest

Hospital
Nepean Hospital - Kingswood

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
The Prince Charles Hospital - Chermside

Hospital
Sunshine Coast University Hospital - Birtinya

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Liverpool Hospital - Liverpool

Postcode
2065 - St Leonards

Postcode
2086 - Frenchs Forest

Postcode
2747 - Kingswood

Postcode
3000 - Melbourne

Postcode
3084 - Heidelberg

Postcode
4032 - Chermside

Postcode
4575 - Birtinya

Postcode
3168 - Clayton

Postcode
2170 - Liverpool

Anticipated date of first participant enrolment31/08/2022

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

1.	Adults, aged 18 years and older, with either: 
a)	newly diagnosed, treatment naïve metastatic (Stage IV) non-squamous NSCLC, or
b)	recurrent non-squamous NSCLC with no disease progression for at least 6 months following prior curative lung surgery and (neo)adjuvant chemotherapy, or prior curative concurrent chemoradiotherapy and immunotherapy maintenance, for non-resectable stage III cancer. 
2.	Presence of KRAS G12C mutation in tumour tissue 
3.	Sufficient tumour tissue should be available for molecular profiling by Next Generation Sequencing (NGS) or results available from molecular profiling of tumour tissue by NGS. If there is insufficient tissue for NGS testing, a repeat biopsy is strongly recommended. Acceptable platforms include, but are not limited to: FoundationOne Tissue CDx, Illumina TruSight Oncology 500 (TSO500)
4.	Measurable disease according to RECIST 1.1. Lesions previously irradiated are not considered measurable unless they have unequivocally progressed after radiation.
5.	ECOG performance status of 0 or 1
6.	Adequate bone marrow function within 14 days prior to registration:
•	Platelets greater than or equal to  100 x 109/L
•	Absolute neutrophil count (ANC) greater than or equal to  1.5 x 109/L 
•	Haemoglobin greater than or equal to  90 g/L
•	International normalized ratio (INR) less than or equal to  1.5
•	activated partial thromboplastin time (aPTT) less than or equal to  1.5 x ULN
7.	Adequate liver function within 14 days prior to registration:
•	Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to  2.5 x institutional upper limit of normal (ULN) (or less than or equal to  5 x ULN if liver metastases are present).
8.	Adequate renal function with no proteinuria within 14 days prior to registration:  
•	Creatinine clearance greater than or equal to 60 mL/min. This can be determined using any of the following: 51Cr-EDTA, 99mTc-DTPA renography, 24-hour urine collection for creatinine clearance, or estimated using the Cockcroft-Gault formula
•	Urine dipstick with no proteinuria (i.e. either 0, trace, or 1+). If urine dipstick is greater than 1  then 24-hour urine collection is required, and must demonstrate less than or equal to  500 mg protein per day
9.	QTc less than or equal to  470 msec in females and less than or equal to  450 msec in males (based on average of screening triplicates)
10.	Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments 
11.	Signed, written informed consent (main study and tissue banking).  

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Previous treatment with sotorasib, or KRAS G12C specific inhibitor, or pan-KRAS inhibitor
2.	Concurrent driver mutation (including EGFR, ALK, ROS1, BRAF) where an approved targeted therapy is available 
3.	Mixed histology with any small cell or squamous component
4.	Evidence of active bleeding or bleeding risk, including:
•	a tumour that compresses or invades major blood vessels or tumour cavitation that in the opinion of the investigator is likely to bleed
•	History of haemoptysis (>2.5 mL per event) in the last 3 months or severe bleeding
•	Bleeding disorders, haemorrhagic diathesis
•	Chronic systemic anticoagulation with aspirin > 100 mg/day, clopidogrel > 75 mg/day, ticagrelor > 90 mg BD, more than one anti-platelet drug, warfarin, heparin, enoxaparin, and other direct oral anticoagulants (e.g. apixaban, rivaroxaban, etc) 
5.	Medically uncontrolled hypertension or systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg. If “white coat” hypertension is suspected, a 24-hour continuous blood pressure recording is required to accurately determine blood pressure. 
6.	Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to registration, unstable arrhythmias, or unstable angina
7.	Significant peripheral vascular disease or cerebrovascular disease (including stroke or transient ischaemic attack within 6 months prior to registration)
8.	Concurrent medical illness that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
9.	Severe infection within 4 weeks prior to registration including, but not limited to hospitalisation for management of infection, bacteraemia or sepsis.
10.	Active hepatitis B, hepatitis C, or HIV. Chronic hepatitis B carrier with undetectable hepatitis DNA level is allowed. Serological testing is not mandatory unless clinically indicated. 
11.	Major surgery within 28 days prior to registration 
12.	Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to swallow oral tablet medication
13.	History of a malignancy within 5 years prior to registration except for non-melanomatous carcinoma of the skin
14.	Spinal cord compression, symptomatic and unstable brain metastases, except for those participants who have completed definitive therapy, are not on steroids equivalent to oral prednisone of > 10 mg/day, and have a stable neurological status for at least 2 weeks after commencement of the definitive therapy. Participants with untreated asymptomatic brain metastases can be eligible for inclusion if immediate definitive treatment is not indicated
15.	Leptomeningeal disease
16.	Known allergy or hypersensitivity to any of the study drugs or their excipients 
17.	Life expectancy of less than 3 months
18.	Current enrolment or participation in another clinical study with an unregistered investigational product during the last 12 months, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study, in which case eligibility should be discussed with the Study Chair by contacting the NHMRC CTC.
19.	Serious medical or psychiatric conditions that might limit the ability of the participant to comply with the protocol. 
20.	Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception

Trial summary

This is an observational study which aims to see if levels of circulating tumour cells (CTCs) mobilised during curative-intent radiotherapy (RT) for non-small cell lung cancer (NSCLC) can be used to predict disease progression and development of metastases.

Who is it for?
You may be eligible for this study if you are aged 18 years or older and you have been deemed eligible to receive RT for NSCLC after positron emission tomography (PET) staging.

Study details
All participants will have collection of blood samples to measure the level of CTCs, pre-treatment, up to 3 pre-defined intervals (24 hours after commencement of radiotherapy, midway through radiotherapy, and final week of radiotherapy) throughout treatment and at disease assessment. A further sample will be taken at the time of suspected relapse, should this occur. These samples are collected on days participants are already attending the hospital.  This will then be analysed to determine the correlation with survival, metastasis, local disease progression, and thromboembolic events (i.e. the development of blood clots) as determined by a review of medical records. The DNA of CTC samples will also be assessed to determine whether this influences any of the above parameters. 

Participants will be followed up in clinic as per standard of care requirements at 3 monthly intervals from completion of radiotherapy (or more often if required clinically) until last patient enrolled completes one year follow up.

It is hoped that this study may show whether changes in CTC or CTC DNA levels after radiotherapy may have prognostic significance. Although this will not influence your current treatment, this may be used to inform the treatment of patients with NSCLC in future.

Broad Health ConditionNon-Small Cell Lung Cancer

Specific Health ConditionCancer
Lung - Non small cell

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of last participant enrolment31/12/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Patients eligible for curative Radiation Therapy for Non-Small Cell Lung Cancer after PET staging

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Low Tumour burden (Largest Tumour <2cm in diameter). Women who are pregnant or lactating.

Trial summary

This study is aiming to determine whether one of two needles (that are approved by the Therapeutics and Goods Administration) is better than the other for taking samples from mediastinal (chest) lymph nodes for the diagnosis of lung cancers.

Who is it for?
You may be eligible for this study if you are aged 18 or older and you have been referred by your doctor to undergo a chest lymph node biopsy procedure known as Transbronchial Node Aspiration by Endoscopic Ultrasound. Participants may have a known cancer diagnosis or will be undergoing this procedure to determine a final diagnosis such as, but not limited to, lung cancer, sarcoidosis or tuberculosis.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin), to undergo a biopsy by one needle (Acquire), or the other (ViziShot). The biopsy procedure will involve giving anaesthetics then examining airways using a camera passed via vocal cords. Both procedures will be the same, the only difference will be which needle is used. 7- 10 days after the procedure, a member of the research team will phone all participants to check if they have experienced any side effects potentially related to the procedure, including going to the emergency department.

It is hoped this research will determine whether one needle is superior to the other, and this may then improve current practice by reducing the number of biopsies needed.

Broad Health Conditionmediastinal lymphadenopathy
lung cancer

Specific Health ConditionRespiratory
Other respiratory disorders / diseases
Cancer
Lung - Non small cell
Cancer
Lung - Small cell

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Hospital
Lyell McEwin Hospital - Elizabeth Vale

Postcode
5112 - Elizabeth Vale

Anticipated date of last participant enrolment2/02/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

All patients referred to Transbronchial Node Aspiration (TBNA) by Endoscopic Ultrasound (EBUS) that meet the following criteria:
- Adults (defined as older than or equal to 18 years of age). There is no upper limit of age provided participants can consent.
- Outpatient/Elective admission to perform the procedure
- Not on anticoagulation (or withheld prior to procedure). Aspirin is ok
- Able to consent
- First TBNA (linear) EBUS (not a redo procedure and no linear EBUS with last 8 weeks).
- Repeat EBUS due to participants intolerance is considered to be failure of bronchoscopy/sedation rather than failure of biopsy needle. The failed procedure results will be not be counted 
- At least 1 lymph node size greater or equal to 10 mm

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

-	Unable to consent, this includes but not limited to participants with dementia, intellectual difficulties, or inability to communicate.
-	Contraindication to taking biopsy – ie on anticoagulation or dual antiplatelets therapy within 48 hrs of procedure or INR > 1.5
-	Inpatients (due to being sick, likely less time to consider participation and making an informed consent). To clarify, inpatients refer to patients who were admitted via emergency department and does not include elective admission to facilitate a procedure or investigations such as who live far away from Lyell McEwin Hospital.

Trial summary

This is a longitudinal observational study that will monitor the health of Western Australians who have been exposed to asbestos through an annual clinical review.

Who is it for?
You may be eligible for this study if you are a resident of Western Australia aged 16 years or older, you are an asbestos exposed ex-worker and/or ex-resident of Wittenoom (the asbestos mine), or if you are an individual with more than 3 months cumulative asbestos exposure and/or radiological evidence of asbestos related disease. 

Study details
All participants who choose to enrol in this study will be asked to undergo a general and lung health assessment, lung function tests and an ultra-low dose CT scan of the chest to look for lung disease from asbestos. The Western Australian Asbestos Review Program (ARP) also performs blood tests to see if we can find markers of lung disease to help diagnose problems earlier. Each of these investigations will be completed annually, the appointment usually takes about two hours. The ARP has no limit on age or how long it is since first exposure to asbestos – the study aims to follow as many people exposed to asbestos for as long as possible. 

It is hoped this research will provide important information that will allow clinicians to further characterise, diagnose and understand asbestos-related diseases. This information may then be used to improve health outcomes of future patients who have been affected by asbestos exposure.

Broad Health Conditionasbestos related diseases
lung cancer
mesothelioma
Pneumoconiosis

Specific Health ConditionRespiratory
Other respiratory disorders / diseases
Cancer
Lung - Mesothelioma
Cancer
Lung - Non small cell

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Hospital
Sir Charles Gairdner Hospital - Nedlands

Postcode
6009 - Nedlands

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Women and men who fulfil one or more criteria:
•	Minimum of 3 months cumulative exposure to asbestos 
•	Any Wittenoom resident/worker and/or
•	Evidence of asbestos related disease on radiological imaging  

Minimum age16 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	<16 years of age
•	Unstable or untreated medical condition that requires intervention or management
•	Unable to attend annual appointments or comply with the study requirements

Trial summary

The aim of this study is to compare the opportunistic use of chest computed tomography (CT) scans obtained as part of the International Lung Screening Trial (ILST) and clinical fracture risk prediction tools, against the reference standard dual-energy X-ray absorptiometry (DXA) scan to detect osteoporosis in lung cancer screenees.

Who is it for?
You may be eligible for this study if you are a lung cancer screening participant currently enrolled in the Queensland site (based at The Prince Charles Hospital) of the Osteoporosis Sub-study of the International Lung Screening Trial (ILST), and you are either due to have your second CT scan soon or have had your second CT scan within the past 6 months. 

Study details
In addition to the CT scan received as part of the ILST trial and the osteoporosis questionnaires completed as part of the Osteoporosis sub-study of the ILST, all participants enrolled in this study will be requested to have a single DXA scan, This DXA scan will be performed either on the same day or different day to your CT scan, but should be within 6 months of the CT scan. The DXA study should only take up to 20 minutes and will be performed at The Prince Charles Hospital. 

It is hoped that this study will demonstrate that CT-based methods will be highly accurate, and have higher discriminative ability compared to clinical risk tools, in classifying DXA-defined osteoporosis, and therefore may validate their use in diagnosing osteoporosis in lung cancer screenees. This, in turn, may help to facilitate early diagnosis and treatment in this high-risk group of lung cancer screening participants.

Broad Health ConditionOsteoporosis
Vertebral fracture
Lung cancer screening
Quantitative computed tomography
Dual-energy x-ray absorptiometry

Specific Health ConditionMusculoskeletal
Osteoporosis
Musculoskeletal
Other muscular and skeletal disorders
Respiratory
Other respiratory disorders / diseases
Cancer
Lung - Non small cell
Cancer
Lung - Small cell

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
The Prince Charles Hospital - Chermside

Postcode
4032 - Chermside

Anticipated date of last participant enrolment3/01/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

-Participants enrolled in the ILST (men and women, aged 55-80 years, current or former smokers quit <15 years prior, >=30 pack-year smoking history and/or estimated lung cancer risk >=1.51% based on the PLCOm2012 risk prediction model, ECOG performance status 0 or 1) who are also volunteers in the ILST osteoporosis sub-study
-Participants who provide written consent.

Minimum age55 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Exclusion criteria per ILST:
• Clinical symptoms suspicious for lung cancer Exclusion criteria:
• Concurrent major medical illness (Any medical condition that, in the investigator’s opinion, may jeopardize the subject’s safety during participation in the study or mean that the subject is unlikely to benefit from screening due to shortened life expectancy)
• Previous lung cancer
• Other non-curatively treated non-pulmonary cancer or <5 years cancer-free if previous cancer
• Pneumonia/bronchitis requiring antibiotics within previous 12 weeks
• CT chest within the last 2 years
• Received chemotherapy/other cytotoxic drugs within the last 6 months
• Pregnancy 
• Unwilling/unable to have chest CT

Trial summary

The purpose of this study is to determine incidence and clinical outcomes of KRASG12C mutated advanced non-small cell lung cancer patients in Australian cancer therapy centres. 

Who is it for
You may be eligible for this study if you, were diagnosed with advanced NSCLC with the presence of a KRAS G12C mutation between Jan 2018 and Dec 201 , and are a patient at one of the participating sites.

Study Details
Participants in this study will continue to receive routine clinical care, which will not be impacted by involvement in this study. Enrolled participants will have clinical data collected from one time point from their medical record. Data captured will include patient characteristics, disease characteristics, surgical and or drug treatments administered, survival, and treatment outcomes. Data will be collected at a single point by study personnel from the patient medical record. 

This study aims to help Oncologist better understand the incidence, demographics, disease characteristics and survival outcomes of KRASG12C mutated advanced NSCLC in Australia. This may ultimately lead to improved standard of care practices which will improve patient outcomes.

Broad Health ConditionLung Cancer

Specific Health ConditionCancer
Lung - Non small cell

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,QLD,SA,TAS,WA,VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
The Queen Elizabeth Hospital - Woodville

Hospital
Royal Hobart Hospital - Hobart

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
Wollongong Hospital - Wollongong

Hospital
GenesisCare – North Shore - St Leonards

Hospital
Cabrini Hospital - Malvern - Malvern

Hospital
The Prince Charles Hospital - Chermside

Hospital
Westmead Hospital - Westmead

Hospital
Fiona Stanley Hospital - Murdoch

Hospital
Latrobe Regional Hospital - Traralgon

Hospital
Bendigo Health Care Group - Bendigo Hospital - Bendigo

Hospital
Austin Health - Austin Hospital - Heidelberg

Postcode
3000 - Melbourne

Postcode
2065 - St Leonards

Postcode
2050 - Camperdown

Postcode
5011 - Woodville

Postcode
7000 - Hobart

Postcode
6009 - Nedlands

Postcode
2500 - Wollongong

Postcode
3144 - Malvern

Postcode
4032 - Chermside

Postcode
2145 - Westmead

Postcode
6150 - Murdoch

Postcode
3844 - Traralgon

Postcode
3550 - Bendigo

Postcode
3084 - Heidelberg

Anticipated date of first participant enrolment25/10/2021

Anticipated date of last participant enrolment11/06/2024

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1. Patients with histologically (or cytologically) confirmed advanced non-small cell lung cancer who are diagnosed and referred to a participating centre for consideration of systemic treatment between 1 January 2018 - 31 December 2019
2. Centres that are routinely requesting KRASG12C testing or a panel that includes KRASG12C testing. Molecular data including the presence or absence of KRASG12C mutation must be available 
3. Clear documentation  of  date of tissue diagnosis of advanced NSCLC, clinical presentation, medical co-morbidities, performance status, treatment options delivered, response assessment, therapy duration, reason for treatment discontinuation, site(s) of disease progression and survival data. 
4. Patients with any site of metastatic disease including brain metastases

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Patients who were initially diagnosed and referred for systemic treatment before 1 January 2018  
2. Patients with absent key tumour, treatment or outcome data
3. Patients in whom KRAS status is unknown

Trial summary

This study aims to investigate whether priming intravenous administration sets with monoclonal antibodies reduces chair time.

Who is it for?
You may be eligible for this study if you are an adult being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab at the Royal Brisbane and Women's Hospital.

Study details
Participants will randomly be allocated to one of two groups: one which has their IV line primed with the treatment drug, and one which is primed with diluent only before administration of the drug. Information on treatment duration, adverse reactions and patient experience will be collected on the day.

Information from this trial will inform the optimisation of patient flow and decreased hypersensitivity reactions in oncology care.

Broad Health ConditionMyeloma
Lekaemia
Lymphoma
Lung Cancer
Melanoma

Specific Health ConditionCancer
Myeloma
Cancer
Leukaemia - Chronic leukaemia
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Lung - Non small cell
Cancer
Malignant melanoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1.     Patients attending the Oncology Day Therapy Unit or Oncology Procedure Unit
2.	18 years or older
3.	Are being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab. 
4.	Any cycle of a patient’s treatment regime (e.g, 1st, 2nd, 3rd dose)

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

The exclusion criteria:
1.	Under 18 years of age
2.	Patients receiving treatment with a monoclonal antibody as an inpatient or at North Lakes
3.	Patients receiving any other monoclonal antibodies that do not meet the criteria of inclusion drugs, chemotherapy, supportive therapies or treatment as part of a pharmaceutical clinical trial
4.	No funding to approach patients who require a translator 

Trial summary

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of tepotinib in a population of participants with metastatic non-small cell lung cancers (NSCLC) harbouring METex14 skipping mutations identified using comprehensive genomic profiling (CGP).

Who is it for?
You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed metastatic NSCLC. Your tumour will need to harbour METex14 skipping mutations identified using CGP.

Study details:
Participants will receive tepotinib treatment. The tepotinib is to be taken orally, at 500mg once daily (days 1 to 21 in a 21-day treatment cycle).
Tepotinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 6 weekly intervals from first treatment until 18 weeks, and then 12 weekly intervals until progression. Safety and tolerability of treatment will be assessed at 3 weekly intervals. Health related quality of life during treatment will be assessed at 3 weekly intervals and then every 9 weeks after end of treatment for 12 months, and then every 12 weeks until progression.

We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that tepotinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Broad Health ConditionAdvanced non-small cell lung cancer harbouring MET exon 14 skipping mutations

Specific Health ConditionCancer
Lung - Non small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Royal Darwin Hospital - Tiwi

Hospital
Royal Hobart Hospital - Hobart

Hospital
Linear Clinical Research - Nedlands

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
The Prince Charles Hospital - Chermside

Hospital
Westmead Hospital - Westmead

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Austin Health - Austin Hospital - Heidelberg

Postcode
3000 - Melbourne

Postcode
5000 - Adelaide

Postcode
0810 - Tiwi

Postcode
7000 - Hobart

Postcode
6009 - Nedlands

Postcode
4102 - Woolloongabba

Postcode
4032 - Chermside

Postcode
2145 - Westmead

Postcode
3065 - Fitzroy

Postcode
2065 - St Leonards

Postcode
3084 - Heidelberg

Anticipated date of first participant enrolment1/07/2021

Anticipated date of last participant enrolment1/07/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

1. Adults, aged 18 years and older, with newly diagnosed metastatic non-squamous NSCLC; 
2. METex14 skipping mutation identified using CGP; 
3. Confirmation of molecular eligibility by the molecular tumour board;
4. Measurable disease as assessed by RECIST 1.1; In the event of evaluable but non-measurable disease, eligibility must be confirmed by the ASPiRATION study chair or delegate through contacting the NHMRC CTC;
5. ECOG 0 to 2; 
6. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
a. bone marrow function; platelets greater than or equal to 100 x 10^9/L, ANC greater than or equal to 1.5 x 10^9/L, and haemoglobin greater than or equal to 90g/L (5.6mmol/L); 
b. liver function; ALT/AST less than or equal to 3xULN (in the absence of liver metastases, less than or equal to 5xULN for patients with liver involvement) and total bilirubin less than or equal to 1.5xULN;
c. renal function; serum creatinine less than or equal to 1.5xULN;
7. Life expectancy greater than or equal to 12 weeks;
8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
9. Signed, written informed consent to participation in the specific treatment substudy.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Prior systemic therapy for advanced disease. Up to two cycles of systemic therapy (excluding prior MET inhibitor treatment) while awaiting the results of CGP testing are permitted. 
2. Prior MET/HGF pathway inhibitor treatment; 
3. Known history of hypersensitivity or contraindication to tepotinib; 
4. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with tepotinib, including:
a. Known history of interstitial lung disease or drug-induced pneumonitis requiring steroid treatment
b. Congenital QT syndrome or baseline QTc >500ms
5. Active CNS involvement. Patients with stable neurological function, on stable anticonvulsants and/or steroids less than or equal to 10 mg prednisone equivalent over 4 weeks are eligible;
6. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
7. Treatment with any of the following anti-cancer therapies prior to the first dose of tepotinib:
a. Radiation therapy, major surgery, or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions; 
b. Any systemic therapy within 28 days prior to the first dose of tepotinib;
8. Administration of any investigational treatment within 28 days prior to receiving the first dose of tepotinib;
9. Prior or concurrent malignancy. History of another primary malignancy except for:
a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence; 
b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
c. Adequately treated carcinoma-in-situ without evidence of disease;
10. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

Trial summary

This trial aims to determine the safety, feasibility, and efficacy of a combination of chemotherapy, immunotherapy, and chest radiation therapy in extensive stage small cell lung cancer.

Who is it for?
You may be eligible for this study if you are 18 or above and have untreated extensive stage small cell lung cancer.

Study details
Participants will be given durvalumab (an immunotherapy drug) concurrently with 4 cycles of cisplatin/carboplatin and etoposide chemotherapy, which is given as in injection every three weeks over approx. 12 weeks. 
Maintenance treatment with durvalumab alone will continue every 4 weeks after the completion of the chemotherapy cycles until there is evidence of disease progression.

Participants will also receive 10 chest radiotherapy sessions, which will take approx. 2 weeks to complete (given either concurrently with cycle 3 or 4 of chemotherapy (called concurrent radiotherapy) or within 6 weeks of finishing chemotherapy (called consolidation radiotherapy). Fractions are expected to be delivered daily. When RT is to start depends on the location and size of the area to be treated). 
Throughout the study, participants will be monitored regularly for any adverse effects, and for progression of disease using a number of imaging techniques.

It is hoped that this study may demonstrate that chest radiation is safe and beneficial when given in combination with chemotherapy and immunotherapy for the treatment of extensive stage small cell lung cancer.

Broad Health ConditionCancer
Extensive Stage Small Cell Lung Cancer
Lung Cancer

Specific Health ConditionCancer
Lung - Small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC

Hospital
Westmead Hospital - Westmead

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Liverpool Hospital - Liverpool

Hospital
Blacktown Hospital - Blacktown

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Princess Alexandra Hospital - Woolloongabba

Postcode
2145 - Westmead

Postcode
3084 - Heidelberg

Postcode
2170 - Liverpool

Postcode
2148 - Blacktown

Postcode
4029 - Herston

Postcode
4102 - Woolloongabba

Anticipated date of first participant enrolment4/01/2022

Anticipated date of last participant enrolment31/07/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

-	Age greater than or equal to 18, 
-      Untreated ES-SCLC patients
-	Provided written informed consent 
-	Histologically or cytologically documented ES-SCLC - ES-SCLC defined as; American Joint Committee on Cancer [8th edition] SCLC stage IV 
• T any, N any, M1 a/b/c, 
or 
 • T3?4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a feasible radiation plan 
-	ECOG performance-status score of 0 or 1 at registration. Patients with worse performance status (PS) prior to cycle 1 may be included if PS improves to 0-1 prior to cycle 2; these patients would be registered prior to cycle 2 
-	Life expectancy greater than or equal to 12 weeks at registration 
-	Brain metastases must be controlled or asymptomatic
-	Thoracic disease deemed suitable for radiation therapy following initial systemic therapy
-	Bodyweight of at least 30 kg
-	Suitability for first-line platinum-based chemotherapy
-	Adequate organ and marrow function; and negative pregnancy test for pre-menopausal women
-	No prior exposure to immune-mediated therapy including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen-4, anti-programmed cell death-1, anti-programmed cell death ligand-1, and anti-programmed cell death ligand-2 antibodies, excluding therapeutic anticancer vaccines. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	Previous high dose radiotherapy to the chest precluding mediastinal radiation
•	Significant active or previous autoimmune or inflammatory disorder
•	Paraneoplastic syndrome of autoimmune nature requiring systemic treatment
•	Interstitial lung disease/pulmonary fibrosis 
•	History of active primary immunodeficiency
•	Uncontrolled, concurrent illness or active infections

Trial summary

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of alectinib in a population of participants with newly diagnosed metastatic non-squamous small cell lung cancer (NSCLC) or patients with advanced cancers harbouring ALK gene alterations identified using comprehensive genomic profiling (CGP). 

Who is it for?
You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic NSCLC or solid tumour of any histologic type or an earlier diagnosis of a poor prognosis cancer. Your tumour will need to harbour ALK gene alterations identified using CGP. 

Study details:
Participants will receive alectinib treatment. The alectinib is to be taken orally, at 600mg twice daily (days 1 to 28 in a 28-day treatment cycle). 
Alectinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals from first treatment until progression. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression.

We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Alectinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Broad Health ConditionCancer
ALK gene alterations
Non-small cell lung cancer

Specific Health ConditionCancer
Any cancer
Cancer
Lung - Non small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Linear Clinical Research - Nedlands

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
St George Hospital - Kogarah

Hospital
Westmead Hospital - Westmead

Hospital
Royal Hobart Hospital - Hobart

Hospital
Royal Darwin Hospital - Tiwi

Postcode
2065 - St Leonards

Postcode
4102 - Woolloongabba

Postcode
6009 - Nedlands

Postcode
3000 - Melbourne

Postcode
5000 - Adelaide

Postcode
2217 - Kogarah

Postcode
2145 - Westmead

Postcode
7000 - Hobart

Postcode
0810 - Tiwi

Anticipated date of first participant enrolment1/04/2021

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

1. Adults, aged 18 years and older, with either:
   a. newly diagnosed metastatic non-squamous NSCLC identified through the ASPiRATION molecular screening program OR
   b. advanced and/or metastatic solid cancer of any histologic type, refractory or unsuitable for standard therapies for that cancer type, identified through the MoST molecular screening program;
2. Harbouring a targetable ALK gene alteration identified using CGP and determined by the molecular tumour board. NSCLC patients who have an ALK gene alteration determined by IHC must be confirmed by NGS; Pan cancer patients who have ALK overexpression determined by IHC or rearrangement diagnosed by FISH must be confirmed by NGS;
3. NSCLC patients identified through the ASPiRATION molecular screening program must be FISH-negative, i.e. not eligible for PBS-reimbursed ALK-targeted treatment; 
4. Confirmation of molecular eligibility by the molecular tumour board;
5. Measurable disease as assessed by RECIST 1.1 and/or RANO;. (Exception: newly diagnosed metastatic, non-squamous NSCLC participants with evaluable but non-measurable disease may be approved on a case-by-case basis by contacting the study chair or delegate through the NHMRC CTC). 
6. ECOG 0 to 2; 
7. If the CNS is involved (either primary or metastatic disease), this must be asymptomatic or previously treated and controlled either with local treatment or by steroids; radiation treatment must be completed at least 14 days before enrolment and patients must be clinically stable;  
8. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
   a. bone marrow function; platelets equal 100 x 109/L, ANC equal 1.5 x 109/L, and haemoglobin equal 90g/L (5.6mmol/L); 
   b. liver function; ALT/AST equal 3 x ULN (in the absence of liver metastases, equal 5 x ULN for patients with liver involvement) and total bilirubin equal 1.5xULN;
   c. renal function; serum creatinine equal 1.5xULN;
9. Prior anticancer therapy:
   a. For newly diagnosed metastatic, non-squamous NSCLC:
       i. Up to 2 cycles of systemic therapy while awaiting the results of CGP testing are permitted (but not required);
   b. For advanced and/or metastatic treatment-refractory solid cancer of any histologic type:
       i. Participants must have received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists, 
       ii. Clinical or radiological progression on or following last anticancer therapy unless such anticancer therapy stopped due to toxicity / treatment intolerance, 
       iii. Patients previously treated with an ALK inhibitor (other than alectinib) are eligible, unless there is a known on-target resistant mutation (e.g. G1202R) or a compelling off-target resistance mechanism that is deemed unlikely to respond to alectinib, as determined by the MTB. The tumour sample must be obtained from a progression biopsy for genomic screening instead of the archival sample; 
10. Life expectancy of at least 12 weeks
11. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
12. Signed, written informed consent to participation in the specific treatment substudy.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Prior ALK pathway inhibitor treatment; 
2. Known history of hypersensitivity or contraindication to alectinib, or to any of the additives in the alectinib drug formulation; 
3. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with alectinib, including:
    a. GI disorder that may significantly affect absorption of oral medications, such as malabsorption syndromes or status post-major bowel resection
    b. Symptomatic bradycardia
4. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
5. Treatment with any of the following anti-cancer therapies prior to the first dose of alectinib:
    a. Radiation therapy, major surgery, or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions; 
    b. Any systemic therapy within 28 days prior to the first dose of alectinib;
6. Administration of any investigational treatment within 28 days prior to receiving the first dose of alectinib;
7. Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g. hearing loss, peripheral neuropathy);
8. Prior or concurrent malignancy. History of another primary malignancy except for:
    a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence; 
    b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
    c. Adequately treated carcinoma-in-situ without evidence of disease;
    d. For participants with treatment-refractory solid tumours, a concurrent or past history of competing malignancy within 2 years, prior to molecular screening registration, is eligible, unless the competing malignancy is expected to lead to a shorter survival than the index malignancy;
9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or agree to use a highly effective form of contraception. Women of childbearing potential must have a negative pregnancy test done within 3 days prior to registration. Men with partners of childbearing potential must have been surgically sterilised or agree to use a highly effective form of contraception. 

Trial summary

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of Entrectinib advanced cancers harbouring NTRK or ROS1 gene alterations identified using comprehensive genomic profiling. 

Who is it for?
You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any cell type or an earlier diagnosis of a poor prognosis cancer and have received all standard anticancer therapy, or if you have newly diagnosed metastatic non-small cell lung cancer. Your tumour will need to have an NTRK fusion or ROS1 gene alterations. 


Study details
Participants will continue to receive Entrectinib orally at a dose of 600 mg every 28 days continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals for 12 months and then 12 weekly, or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will be assessed at 4 weekly intervals.

We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that entrectinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Broad Health ConditionCancer

Specific Health ConditionCancer
Lung - Non small cell
Cancer
Any cancer

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
The Canberra Hospital - Garran

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Linear Clinical Research - Nedlands

Hospital
Royal Darwin Hospital - Tiwi

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Westmead Hospital - Westmead

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
The Prince Charles Hospital - Chermside

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal Hobart Hospital - Hobart

Postcode
2605 - Garran

Postcode
3000 - Melbourne

Postcode
5000 - Adelaide

Postcode
6009 - Nedlands

Postcode
0810 - Tiwi

Postcode
2065 - St Leonards

Postcode
2145 - Westmead

Postcode
3065 - Fitzroy

Postcode
4032 - Chermside

Postcode
4102 - Woolloongabba

Postcode
7000 - Hobart

Anticipated date of first participant enrolment1/06/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

1. Adults, aged 18 years and older with either pathologically confirmed:
    a. newly diagnosed metastatic, non-squamous NSCLC identified through the ASPiRATION molecular screening program OR
    b. advanced and/or metastatic solid cancer of any histologic type, refractory or unsuitable for standard therapies for that cancer type, identified through the MoST molecular screening program.
2. Harbouring an NTRK fusion or ROS1 activating gene alteration identified using CGP
3. NSCLC patients identified through the ASPiRATION molecular screening program must be FISH-negative, i.e. ineligible for PBS-reimbursed ROS1-targeted treatment
4. Confirmation of molecular eligibility by the molecular tumour board (MTB)
5. Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and/or RANO.
6. ECOG 0-2
7. If the CNS is involved (either primary or metastatic disease), this must be asymptomatic or previously treated and controlled either with local treatment or by steroids
8. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
    a. bone marrow function; platelets greater than or equal to 100 x 10^9/L, ANC greater than or equal to 1.5 x 10^9/L, and haemoglobin greater than or equal to 90g/L;
    b. liver function; ALT/AST less than or equal to 2.5 x ULN (in the absence of liver metastases, ALT/AST less than or equal to 5 x ULN for patients with liver metastases) and total bilirubin =1.5xULN;
    c. renal function; serum creatinine less than or equal to 1.5xULN;
9. Prior anticancer therapy (excluding TRK or ROS1 inhibitors)
    a. For newly diagnosed metastatic, non-squamous NSCLC:
        i. Up to 2 cycles of systemic therapy while awaiting the results of CGP testing are permitted (but not required);
    b. For advanced and/or metastatic treatment-refractory solid cancer of any histologic type:
        i. Participants must have received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists.
        ii. Clinical or radiological progression on or following last anticancer therapy unless such anticancer therapy stopped due to toxicity / treatment intolerance
10. Life expectancy greater than or equal to 12 weeks
11. Willing and able to comply with all study requirements, including treatment (including ability to swallow whole capsules intact, without chewing, crushing, or opening the capsules/tablets), timing and/or nature of required assessments
12. Signed, written informed consent to participation in this specific treatment substudy

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Prior NTRK and/or ROS1 pathway inhibitor treatment (either approved or investigational)
2. Known history of hypersensitivity or contraindication to entrectinib
3. History of prolonged QTc interval (e.g. repeated demonstration of a QTc interval greater than 450 milliseconds from ECGs performed at least 24 hours apart) or use of medications that are known to prolong the QT interval.
4. History of additional risk factors for torsade de pointes (e.g. family history of long QT syndrome)
5. History of recent (within 3 months prior to screening) symptomatic congestive heart failure or clinically significant cardiac dysfunction, as determined by left ventricular ejection fraction (LVEF) less than 50%
6. Peripheral sensory neuropathy grade greater than or equal to 2
7. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
8. Radiation therapy, major surgery, or tumour embolization within 14 days prior to the first dose of entrectinib. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
9. Any systemic therapy within 28 days prior to the first dose of entrectinib
10. Administration of any investigational treatment within 28 days prior to receiving the first dose of entrectinib
11. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with entrectinib, including
    a. Known active infections that would interfere with the assessment of safety or efficacy of entrectinib (bacterial, fungal, or viral, including HIV positive)
    b. Active gastrointestinal disease (e.g. Crohn’s disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably affect drug absorption
12. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
13. Any unresolved toxicity (CTCAE v5.0 greater than grade 2) from previous anti-cancer therapy.
14. Prior or concurrent malignancy except for:
    a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence.
    b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    c. Adequately treated carcinoma-in-situ without evidence of disease
15. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or agree to use a highly effective form of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men with partners of childbearing potential must have been surgically sterilised or agree to use a highly effective form of contraception

Trial summary

What is ASPiRATION?
ASPiRATION is a clinical trial that is testing a new approach to providing personalised treatments for patients with newly diagnosed lung cancer through comprehensive genomic testing of patient’s tumour tissue. The ASPiRATION study is being conducted as part of a larger research project called the Molecular Screening and Therapeutics (MoST) Program. 
In Australia, standard of care tumour testing for lung cancer patients has the ability to identify changes in three genes: EGFR, ALK & ROS1, for which drugs are available on the Pharmaceutical Benefits Scheme (PBS). If a patient is suitable for ASPiRATION, their tumour will also be tested using a technique called comprehensive genomic profiling (CGP), often referred to as molecular screening and/or profiling. This technique allows to look at changes in hundreds of genes in a single test. After a patient’s tumour is tested, a report is sent to the referring oncologist with information on (i) Any genetic biomarkers that were identified in the tumour and (ii) The types of treatment that may be suitable. 
Who is it for? 
a. Adults (>= 18 years of age) with newly diagnosed pathologically confirmed non-squamous non-small cell lung cancer and sufficient tumour tissue for “molecular” testing 
b. Fit to be able to have treatment
Study details: A small part of your tumour tissue, which was collected previously, will be used to identify a biomarker by doing a laboratory analysis (‘molecular screening’). You will be asked to provide information about your and your family’s health background, to donate a blood sample and complete some questionnaires.
Results from molecular screening will be returned to all participants. These results may have implications for your treatment if a suitable biomarker is found.
It is hoped this research will determine whether additional molecular screening can be feasibly integrated into Australian clinical practice for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC).

Broad Health ConditionMetastatic lung cancer
Metastatic non-squamous non-small cell lung cancer (mNSCLC)

Specific Health ConditionCancer
Lung - Non small cell

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
Linear Clinical Research - Nedlands

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal Hobart Hospital - Hobart

Hospital
Westmead Hospital - Westmead

Hospital
Royal North Shore Hospital - St Leonards

Hospital
The Prince Charles Hospital - Chermside

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Royal Darwin Hospital - Tiwi

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
The Alfred - Melbourne

Hospital
Chris O’Brien Lifehouse - Camperdown

Hospital
The Canberra Hospital - Garran

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Border Medical Oncology - Albury

Postcode
6009 - Nedlands

Postcode
5000 - Adelaide

Postcode
3000 - Melbourne

Postcode
4102 - Woolloongabba

Postcode
7000 - Hobart

Postcode
2145 - Westmead

Postcode
2065 - St Leonards

Postcode
4032 - Chermside

Postcode
2010 - Darlinghurst

Postcode
5042 - Bedford Park

Postcode
0810 - Tiwi

Postcode
3065 - Fitzroy

Postcode
2050 - Camperdown

Postcode
2605 - Garran

Postcode
3084 - Heidelberg

Postcode
2640 - Albury

Anticipated date of last participant enrolment31/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1. Male or female patients, aged 18 years and older, with newly diagnosed pathologically confirmed metastatic non-squamous non-small cell lung cancer (mNSCLC); 
a. Exception: patients with a typical pattern of disease recurrence within 12 months following primary resection may not require a confirmatory repeat biopsy, unless the diagnosis is unclear, such as an isolated pulmonary nodule, in which case repeat biopsy should be considered per standard practice; 
b. For mixed or other histologies the following is permitted:
- Mixed adenosquamous where adenocarcinoma is dominant
- Carcinoma not otherwise specified (NOS) favouring adenocarcinoma
- Sarcomatoid carcinoma
2. ECOG performance status 0 or 1. 
3. Sufficient tissue for molecular screening.
4. Willing and able to comply with study requirements. It is the intention to screen patients who are in principle willing to consider participation in a MoST substudy if they are found to have an appropriate tumour biomarker and are still eligible for enrolment at the time of the treatment phase;
5. Current enrolment or participation in another clinical study with an unregistered investigational product during the last 12 months, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study, must first be discussed the Study Team before study enrolment.
6. Signed, written informed consent to participate in molecular profiling and linkage to Medicare data.
7. Have not had any previous treatment for metastatic non-squamous NSCLC; 
a. For patients with symptomatic or bulky disease, where it would be detrimental to delay treatment, systemic therapy may be commenced at the investigator’s discretion whilst awaiting CGP results; 
b. Patients who have had prior treatment with curable intent are eligible.
8. Life expectancy of at least 12 weeks.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Ineligible histology: 
- Mixed small cell lung cancer
- Large cell neuroendocrine carcinoma
2. Comorbidities or conditions (e.g. psychiatric) which may contraindicate participation and/or ability to receive any systemic therapy(s);
3. Comorbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol; 
4. History of another primary malignancy except for: 
a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence
b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
c. Adequately treated carcinoma in situ without evidence of disease

Trial summary

The ImmunoPET study aims to assess whether it is feasible to use 89Zr-durvalumab (89Zr-durva) as a PET tracer of PD-L1 (a cancer related protein) in patients with cancer.

Who is it for?
You may be eligible for this study if you are an adult with non-small cell lung cancer.

Study details
All participants will receive an injection in the arm containing the 89Zr-durva tracer 30 minutes prior to completing a PET scan on Day 0. A further 3 PET scans will be taken 24 hours, 3 days and 5 days after the injection of the 89Zr-durva tracer. Each PET scan will take approximately 30-45 minutes.

Blood tests will be taken at each of these PET scans. About 15-20ml of blood will be taken at each PET scan.

It is hoped that this study will help determine if 89Zr-durvalumab (89Zr-durva) is a feasible option for use as a tracer of PD-L1.

Broad Health ConditionNon Small Cell Lung Cancer

Specific Health ConditionCancer
Lung - Non small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA,VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Sir Charles Gairdner Hospital - Nedlands

Postcode
3000 - Melbourne

Postcode
3084 - Heidelberg

Postcode
6009 - Nedlands

Anticipated date of first participant enrolment1/04/2021

Anticipated date of last participant enrolment31/05/2022

Phase of TrialPhase 0

Has the study received ethics approval?Approved

Key inclusion criteria

1. Written informed consent provided. 
2. Female or male
3. Life expectancy greater than or equal to 12 weeks
4. Minimum age greater than or equal to 18 years, no maximum age. 
5. Body weight >30kg 
6.Patients with NSCLC and with advanced incurable disease, and with metastatic  disease apparent on FDG-PET
7. Histopathology with PD-L1 positive tumour cells >25%. Although, in the metastatic setting >50% is the accepted cut-off, the threshold for Stage III patients remains poorly defined. A cut-off of >25% to broaden the eligibility criteria for enrolment is considered appropriate in this study
8. Subjects with an estimated glomerular filtration rate (eGFR) > 50ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
9. Eastern Cooperative Group Oncology Group (ECOG) performance score of 0-2. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Pregnant or breastfeeding females
2.	Known sensitivity or allergy to anti-PD-L1 agents
3.	Any serious medical condition which the investigator feels may interfere  with the procedures or evaluations of the study
4.	Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

Trial summary

This study is investigating whether routine collection of patient-reported outcome measures electronically at regular timepoints will have an impact on cancer patients symptoms and the number of hospital admissions.

Who is it for?
You may be eligible for this study if you are 18 or older, you have been diagnosed with an invasive solid cancer and you are about to start or have recently started treatment at one of the study hospitals in Queensland.

Study details
Participants enrolled in this study will be allocated to one of two study groups by chance. Participants allocated to the first group will be asked to complete a short questionnaire about their symptoms and any treatment side effects experienced, prior to each treatment visit using a tablet or other electronic device, and again before follow-up visits with their doctor. It is anticipated that filling in the questionnaire will take about 10 minutes. Participants allocated to the second group won't be asked to complete any questionnaires prior to their treatment or follow-up visits, however, they will be asked you to complete questionnaires at regular time points over a 2 year period from consenting to the study.
Two pre-planned sub-studies will assess the effects of the electronic symptom and treatment questionnaires on participants’ partners and/or carers (PROMISE-Carers Substudy) and the relationship between genetic factors and symptoms/wellbeing/outcomes (PROMISE-Genetics Substudy).

It is hoped this research will determine whether additional collection of patient symptoms and any treatment side effects will result more effective cancer patient care and have a positive impact on unplanned hospital presentations/admissions. Two pre-planned sub-studies will assess the effects of the electronic symptom and treatment questionnaires on participants’ partners and/or carers (PROMISE-Carers Substudy) and the relationship between genetic factors and symptoms/wellbeing/outcomes (PROMISE-Genetics Substudy).

Broad Health ConditionCancer

Specific Health ConditionCancer
Bowel - Anal
Cancer
Breast
Cancer
Head and neck
Cancer
Lung - Small cell
Cancer
Pancreatic
Cancer
Prostate
Cancer
Oesophageal (gullet)

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
The Townsville Hospital - Douglas

Hospital
Gold Coast University Hospital - Southport

Postcode
4029 - Herston

Postcode
4102 - Woolloongabba

Postcode
4814 - Douglas

Postcode
4215 - Southport

Anticipated date of first participant enrolment25/01/2021

Anticipated date of last participant enrolment1/02/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Age at least 18 years
diagnosed with invasive solid cancer
about to start or recently started treatment at one of the study sites

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

A tumour type or characteristic that is not appropriate for inclusion at the discretion of the Site Investigator and Coordinating PI e.g.:
o	Will not return to the site for regular treatment/follow-up
o	Already using or would normally use an e-PROM tool at that site
•	Treated with surgery only
•	Current participation in another study that requires completion of similar PROMs
•	Unable to provide informed consent
•	Unable to complete the e-PROM tools remotely (e.g. a comorbid condition affecting vision, cognition or dexterity or no internet access at home) 
•	Unable to complete the study questionnaires in English
•	Unwilling to consent to data linkage
In addition, participants who consent but do not complete the Baseline Study Questionnaire will be excluded post-consent. 

Trial summary

Malignant pleural mesothelioma (MPM) is a rare cancer of the lung lining caused by exposure to asbestos. MPM is regarded as one of the most aggressive solid tumours, with limited treatment options and poor prognosis. Emerging MPM treatment options are of particular interest in Australia where the incidence of MPM is among the highest in the world. One such emerging treatment involves the injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. This approach, termed transarterial chemoperfusion, allows a high concentration of chemotherapy to be delivered directly to the cancer. This study is investigating the safety and effectiveness of transarterial chemoperfusion for the treatment of patients with MPM. We will evaluate tumour response, symptoms, quality of life, progression free survival and overall survival. 
Who is it for?
You may be eligible to participate in this study if you are aged 18 years or older, have been diagnosed with malignant pleural mesothelioma that is not being treated with surgery and you have not had recent chemotherapy (within the last 4 weeks).
Study details
Participants enrolled in this study will undergo an angiogram (imaging of the heart and blood vessels), which involves having a catheter inserted into a vein. The chemotherapy agents will then be directly infused into the aorta and surrounding blood vessels over a period of 60 minutes. All participants will be receive this treatment for at least 2 sessions scheduled every 3-6 weeks, before undergoing a CT scan to assess treatment response. Participants who show a reduction in their tumour burden will continue to receive therapy every 3-6 weeks until they no longer respond to treatment. Participants who do not show a response to treatment after the first 2 procedures will not undergo further infusion therapy. 
It is hoped this research will determine whether this specific method of chemotherapy infusion is a safe and effective treatment for patients with malignant pleural mesothelioma, and can improve outcomes for future patients.

Broad Health ConditionMalignant pleural mesothelioma

Specific Health ConditionCancer
Lung - Mesothelioma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
The Wesley Hospital - Auchenflower

Postcode
4066 - Auchenflower

Anticipated date of first participant enrolment14/07/2022

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

Key inclusion criteria

•	Histologically or cytologically confirmed MPM.
•	Tumour/s assessed as inoperable or refuses surgery.
•	The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment.
•	Failure to respond to first line standard of care chemotherapy.
•	Have measurable disease, by computed tomography (CT) as per modified Response Evaluation Criteria in Solid Tumours (RECIST) for mesothelioma. 
•	Ability to understand and the willingness to sign a written informed consent document.
•	Must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, imaging studies, and other requirements of the study.
•	An ECOG performance status score <3. 
•	Patient is expected to survive and be available for follow up for at least 12 months.
•	Patients must have private health insurance to be included in this trial and eligible for treatment at The Wesley Hospital.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	Large pulmonary-systemic shunting of tumour vasculature, as demonstrated on preliminary angiogram.
•	Patients who have had chemotherapy  within 4 weeks prior to entering the study. 
•	History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, methotrexate, gemcitabine or other agents used during the study. 
•	History of moderate and severe allergic reaction to intravenous iodinated contrast media is not a contraindication to the study. 
•	Involvement in trials with other investigational agents.
•	Patient with synchronous primary tumours requiring other therapy.
•	Uncontrolled intercurrent illness including, but not limited to, renal dysfunction, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•	Women who are pregnant or lactating.

Trial summary

The purpose of this study is to see whether adding durvalumab, a type of immunotherapy, to standard chemotherapy will improve overall survival in patients with pleural mesothelioma (PM).

Who is it for?
Participants may be eligible to join this study if they are aged 18 years or above, and have had a diagnosis of PM that cannot be surgically removed.

Study details:
The study involves allocating participants to receive treatment with standard chemotherapy given with durvalumab (experimental arm), or physician's choice of: chemotherapy alone OR Ipilimumab and Nivolumab immunotherapy (control arm) . These treatments are allocated by chance. Treatment will be given by infusion until disease worsens or you experience unmanageable side effects.

Study treatment:
Chemotherapy and durvalumab (experimental group):
This group will receive standard chemotherapy for mesothelioma (cisplatin or carboplatin and pemetrexed) every 3 weeks (one cycle) for a maximum of 6 cycles (about 18 weeks) plus the experimental treatment durvalumab every 3 weeks on the same day as the chemotherapy. 

After combination treatment has been completed, participants will continue treatment with durvalumab alone every 4 weeks for as long as they are tolerating the treatment well and the mesothelioma is under control. 

Physician's choice of  (control group):
Chemotherapy alone:
This group will receive standard chemotherapy for mesothelioma (cisplatin or carboplatin and pemetrexed) every 3 weeks (one cycle) for a maximum of 6 cycles (about 18 weeks).
OR
Ipilumumab and Nivolumab immunotherapy: This group will receive Ipilimumab every 6 weeks and Nivolumab every 3 weeks or 2 weeks until disease progression, unacceptable toxicity, or up to 2 years.

After treatment has been completed, participants will receive the same care as they would if they were not on a clinical trial.

After stopping treatment, we would like to follow participants up every 6 weeks for the rest of their life. 

Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed Death-Ligand 1 (PD-L1). Blocking PD-L1 helps the body's immune system attack cancer cells. Research has shown that durvalumab can slow tumour growth and shrink tumours in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma.

We plan to enrol 480 participants in this study from hospitals and clinics throughout Australia, New Zealand and the United States of America (USA). Durvalumab is not approved in Australia or any other country for treatment of advanced mesothelioma. Durvalumab is approved for locally advanced lung cancer and advanced bladder cancer in Australia and USA.

It is hoped this research will demonstrate that durvalumab is safe and effective for the treatment of advanced mesothelioma, and that the results of this study will lead to improved outcomes for future mesothelioma patients.

Broad Health ConditionPleural Mesothelioma (PM)

Specific Health ConditionCancer
Lung - Mesothelioma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,QLD,SA,TAS,WA,VIC

Hospital
The Canberra Hospital - Garran

Hospital
Westmead Hospital - Westmead

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Liverpool Hospital - Liverpool

Hospital
Coffs Harbour Base Hospital - Coffs Harbour

Hospital
Gosford Hospital - Gosford

Hospital
Calvary Mater Newcastle - Waratah

Hospital
Blacktown Hospital - Blacktown

Hospital
Nepean Hospital - Kingswood

Hospital
Orange Health Service - Orange

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Epworth Richmond - Richmond

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Goulburn Valley Health - Shepparton campus - Shepparton

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Border Medical Oncology - Albury

Hospital
Sunshine Hospital - St Albans

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
The Townsville Hospital - Douglas

Hospital
The Prince Charles Hospital - Chermside

Hospital
Icon Cancer Care Chermside - Chermside

Hospital
Icon Cancer Care South Brisbane - South Brisbane

Hospital
Royal Melbourne Hospital - City campus - Parkville

Hospital
Sunshine Coast University Hospital - Birtinya

Hospital
Flinders Medical Centre - Bedford Park

Hospital
The Queen Elizabeth Hospital - Woodville

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
Royal Hobart Hospital - Hobart

Hospital
Launceston General Hospital - Launceston

Hospital
Icon Cancer Care Wesley - Auchenflower

Hospital
Northern Cancer Institute- St Leonards - St Leonards

Hospital
Frankston Private Hospital - Frankston

Postcode
2605 - Garran

Postcode
2145 - Westmead

Postcode
2050 - Camperdown

Postcode
2170 - Liverpool

Postcode
2450 - Coffs Harbour

Postcode
2250 - Gosford

Postcode
2298 - Waratah

Postcode
2148 - Blacktown

Postcode
2747 - Kingswood

Postcode
2800 - Orange

Postcode
3000 - Melbourne

Postcode
3121 - Richmond

Postcode
3084 - Heidelberg

Postcode
3630 - Shepparton

Postcode
3168 - Clayton

Postcode
2640 - Albury

Postcode
3021 - St Albans

Postcode
4102 - Woolloongabba

Postcode
4814 - Douglas

Postcode
4032 - Chermside

Postcode
4101 - South Brisbane

Postcode
3050 - Parkville

Postcode
4575 - Birtinya

Postcode
5042 - Bedford Park

Postcode
5011 - Woodville

Postcode
6009 - Nedlands

Postcode
7000 - Hobart

Postcode
7250 - Launceston

Postcode
4066 - Auchenflower

Trial location outside Australia

Country
United States of America

Country
New Zealand

State
Auckland

Anticipated date of first participant enrolment1/02/2021

Anticipated date of last participant enrolment31/01/2024

Phase of TrialPhase 3

Has the study received ethics approval?Approved

Key inclusion criteria

1. Adults (18 years or over) with a histological diagnosis of epithelioid pleural mesothelioma that is not amenable to curative surgical resection. Histological diagnosis requires tumour tissue from an open biopsy, or a core biopsy with a needle of 19 gauge or wider.
2. Measurable disease as per modified RECIST 1.1 (mRECIST 1.1) criteria for assessment of response in pleural mesothelioma, without prior radiotherapy to these sites.
3. Body weight greater than 30kg.
4. ECOG performance status of 0 or 1.
5. Tumour tissue (FFPE) available from standard of care diagnostic biopsy for PD-L1 testing and other correlative biomarker testing at a central laboratory.
6. Life expectancy of at least 12 weeks.
7. Adequate blood tests (done within 14 days prior to randomisation) and with values within the ranges specified below.  Blood transfusions are permissible if completed at least 7 days prior to treatment start.
•	Haemoglobin greater than or equal to 9.0 g/L
•	Absolute neutrophil count greater than or equal to 1.5 x 109/L
•	Platelets greater than or equal to 100 x 109/L
•	Total  bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (except participants with Gilbert’s Syndrome, who are eligible with bilirubin less than or equal to 2.5 ULN)
•	Alanine transaminase less than or equal to 2.5 x ULN, unless liver metastases or invasion are present, in which case it must be less than or equal to 5 x ULN
•	Aspartate aminotransferase less than or equal to 2.5 x ULN, unless liver metastases or invasion are present, in which case it must be less than or equal to 5 x ULN
•	Creatinine clearance (CrCl) greater than or equal to 45 mL/min (use Cockcroft-Gault formula)
NOTE: Carboplatin AUC 5 must be the initial platinum agent of choice in patients with creatinine Cl less than 60 mL/min but greater than or equal to 45 mL/min, or those with clinically reported hearing loss.
8. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient or legal representative must sign a consent form prior to enrolment in the trial to document their willingness to participate.
9. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
10. Women of childbearing potential must use a reliable means of contraception during treatment and for at least 90 days thereafter. Breastfeeding is not permissible during or for at least 90 days after the final study treatment. Men must have been surgically sterilised or use a (double if required) barrier method of contraception if they are sexually active with a woman of child bearing potential.
11. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Non- epithelioid histology (biphasic or sarcomatoid).
2. Prior chemotherapy or other systemic anti-cancer or immunotherapy for PM.
3. Diagnosis based only on cytology or aspiration biopsy with a needle narrower than 19 gauge.
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
a.	Patients with vitiligo or alopecia
b.	Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
c.	Any chronic skin condition that does not require systemic therapy
d.	Patients without active disease in the last 5 years may be included
e.	Patients with celiac disease controlled by diet alone
5.	Any condition requiring systemic treatment with either corticosteroids (greater than 10 mg daily prednisone or equivalent dose of an alternative corticosteroid) or other immunosuppressive medications within 28 days of durvalumab or ipilimumab or nivolumab administration. Intranasal, inhaled or topical steroids or local steroid injections (e.g. intra-articular injection) are permitted in the absence of active autoimmune disease. Standard steroid premedication given prior to chemotherapy or as prophylaxis for imaging contrast allergy should not be counted for this criterion.
6. Participants with symptomatic or uncontrolled brain metastases or leptomeningeal disease are excluded.
7. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
8. Current treatment or treatment within the last 12 months with any investigational anti-cancer products.
9. Concurrent enrolment in another clinical trial testing an anticancer treatment.
10. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) greater than or equal to 470 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome.
11. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment on protocol. Note: Local surgery of isolated lesions for palliative intent is acceptable. Limited pleural biopsy procedures do not apply.
12. No other malignancy that requires active treatment. Participants with a past history of adequately treated carcinoma in situ, non-melanoma skin cancer or lentigo maligna without evidence of disease or superficial transitional cell carcinoma of the bladder are eligible.
13. Hearing loss or peripheral neuropathy considered by the investigators to contraindicate administration of either cisplatin, carboplatin or pemetrexed.
14. History of allergy or hypersensitivity to investigational product, cisplatin, carboplatin, pemetrexed, ipilimumab, nivolumab or any excipient.
15. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive cardiac failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, active peptic ulcer disease or gastritis, serious chronic gastrointestinal conditions associated with diarrhoea, active bleeding diatheses.
16. Hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Exceptions include past or resolved Hepatitis B (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) and patients positive for hepatitis C (HCV) antibody if polymerase chain reaction is negative for HCV RNA. HIV testing is not required in absence of clinical suspicion of HIV.
17. Known history of primary immunodeficiency, allogeneic organ transplant, pneumonitis or active tuberculosis.
18. Receipt of live attenuated vaccination within 30 days prior to enrolment or within 30 days of receiving durvalumab, iplilimumab or nivolumab.
19. Specific comorbidities or conditions or concomitant medications which may interact with the investigational product(s).
20. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
21. Serious medical or psychiatric conditions or social situation that might limit compliance with study requirements, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.

Trial summary

The purpose of this study is to determine if larger doses of radiation given over a shorter period of time, as compared to standard radiation therapy, given with chemotherapy and followed by immunotherapy is safe for participants.

Who is it for?
You may be eligible for this study if you are an adult with non-small cell lung cancer.

Study details
All participants will receive radiation daily with chemotherapy weekly for 4 weeks. They will then receive immunotherapy every fortnight for up to 12 months.

It is hoped that this study will then determine if further research into this treatment method is necessary.

Broad Health Conditionlung cancer

Specific Health ConditionCancer
Lung - Non small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Calvary Mater Newcastle - Waratah

Hospital
Liverpool Hospital - Liverpool

Hospital
Campbelltown Hospital - Campbelltown

Hospital
Blacktown Hospital - Blacktown

Hospital
Westmead Hospital - Westmead

Postcode
2298 - Waratah

Postcode
2170 - Liverpool

Postcode
2560 - Campbelltown

Postcode
2148 - Blacktown

Postcode
2145 - Westmead

Anticipated date of first participant enrolment16/11/2020

Anticipated date of last participant enrolment2/11/2022

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

Unresectable locally advanced Non-small cell lung carcinoma
Considered suitable to receive chemoradiation and immunotherapy
ECOG performance status 0-2

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Unable to meet radiotherapy planning constraints
Previous thoracic radiotherapy
Life expectancy less than 3 years
Received induction chemotherapy prior to chemoradiotherapy