Trial summary

This study will investigate the effect of adding CT imaging to guide the standard endobrachial ultrasound (EBUS) method of collecting lung tissue for the diagnosis of potential lung cancers.

Who is it for?
You may be eligible for this study if you are an adult ages 18 years or older, you live in South Australia and you have been referred to the Royal Adelaide Hospital lung cancer clinic with a pulmonary lesion (suspected lung cancer) that requires a biopsy to be taken. Only participants who are eligible to undergo a radial EBUS procedure will be invited to participate in this study.

Study details
All participants who choose to enrol in this study will undergo a general anaesthetic in order to have the EBUS procedure. The EBUS procedure will be undertaken per the standard method, which involves introducing a flexible camera (bronchoscope) into the participants airway via their throat. An ultrasound probe will also be used to identify the lesion to be biopsied. As part of this study, additional CT imaging will also take place prior to the lesion being biopsied. This imaging will not involve any additional injections and is anticipated to add 15 minutes to the overall procedure and anaesthesia time.

It is hoped this research will determine whether adding CT imaging during the lung biopsy procedure is able to improve the ability of surgeons and physicians to collect the tissue sample accurately and with fewer attempts. If this imaging is found to have a positive impact on the accuracy and duration of the biopsy procedure it may be trialled in a larger number of potential lung cancer patients in a future clinical trial.

Broad Health ConditionLung cancer
bronchoscopy
pulmonary nodule

Specific Health ConditionCancer
Lung - Non small cell

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Hospital
The Royal Adelaide Hospital - Adelaide

Postcode
5000 - Adelaide

Anticipated date of last participant enrolment1/06/2024

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Patients referred to the lung cancer clinic with a peripheral pulmonary lesion that requires a histological diagnosis. Lung nodules with both a high and low pre-test probability of malignancy will be included. Patients will only be included if radial EBUS is the required diagnostic procedure 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients will be excluded if they are unable to give consent, pregnant or likely to be pregnant at the time of recruitment or they are less than 18 years of age. Patients in whom an alternative procedure such as linear EBUS, CT guided biopsy or endobronchial biopsy will also be excluded.  

Trial summary

This study is investigating a new cancer treatment drug, ELVN-002, that may be used for patients with lung cancer.

Who is it for?
You may be eligible for this study if you are a healthy adult aged 18 to 60 years old. Please note that this study will not be enrolling patients with lung cancer.

Study details
This registration is for Part C of a 3-part study investigating ELVN-002. There are two arms in Part C of the study.
Participants enrolled into the CYP3A4 Inhibitor Arm will receive two single dose of ELVN-002 (in capsule form) on separate days. First dose on Day 1 and second dose on Day 7. Participants will also be asked to take a daily dose of itraconazole for 7 days (from Day 4- Day 10). 
Participants enrolled into the CYP3A4 Inducer Arm will receive two single dose of ELVN-002 (in capsule form) on separate days. First dose on Day 1 and second dose on Day 17. Participants will also be asked to take phenytoin 3 times daily for 17 days (from Day 3- Day 19).

Total participation will last up to 10 days for CYP3A4 Inhibitor Arm and 20 days for CYP3A4 Inducer Arm to the clinic for physical examination and vitals assessments and to collect blood and urine samples.

It is hoped that this research will help determine the dose that ELVN-002 can be safely given to patients with lung cancer.

Broad Health ConditionNon-small Cell lung cancer

Specific Health ConditionCancer
Lung - Non small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Hospital
Linear Clinical Research - Nedlands

Hospital
Linear Clinical Research - Joondalup - Joondalup

Postcode
6009 - Nedlands

Postcode
6027 - Joondalup

Anticipated date of last participant enrolment19/07/2023

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

1. Male or female, aged more than 18 to less than 60 years old (both inclusive at the time of informed consent).
2. In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP at the discretion of the PI or designee.
3. Body mass index (BMI) greater than 18 and less than 32.0 kg/m2 at Screening and weight more than 50 kg.
4. Non-smoker (has not used any tobacco products). A participant who smokes less than 2 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week within 3 months prior to Screening can be included in the study if willing and able to stop smoking for the duration of the study, at the discretion of the PI or designee.
5. Clinical laboratory values at Screening (including haematology, biochemistry, coagulation, and urinalysis) within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
6. Acceptable estimated glomerular filtration rate (eGFR) for the study using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation: greater than 89 mL/min/1.73 for participants 18 to 59 years old, or greater than 84 mL/min/1.73 for participants 60 years old).
7. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day -1 and be willing to have additional pregnancy tests as required throughout the study.
8. Female participants who meet 1 of the following criteria will be included.
a. Female participants must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 90 days after the last study procedure is completed. Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Effective forms of contraception include:
• Simultaneous use of intrauterine device (IUD) (non-hormonal) and condom for the male partner.
• Simultaneous use of diaphragm or cervical cap and male condom for the male partner.
• Sterile male partner (vasectomized since at least 6 months prior to first IP administration).
• True abstinence, defined as no sexual intercourse (heterosexual couples). Periodic abstinence and withdrawal are not acceptable methods.
b. Women of non-childbearing potential (WONCBP), defined as postmenopausal for at least more than 12 months, confirmed by follicle stimulating hormone (FSH) levels greater than 40 IU/L, or judged by the Investigator.
9. Male participants must be surgically sterile (more than 90 days since vasectomy with no sperm on sperm analysis; verbal report allowed), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal occlusion, tubal ligation, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or an acceptable, highly effective contraceptive method must be used from Screening until 90 days after the last study procedure is completed. Effective forms of contraception are shown in Inclusion criterion 7.
Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.
10. Able and willing to comply with the study procedure and the restriction specified in the protocol.
11. Able and willing to provide written informed consent after the nature of the study and the potential risk related to participating in the study have been explained and prior to the commencement of any study procedures.
12. Systolic blood pressure of 90 to 140 mmHg and diastolic blood pressure of 40 to 90 mmHg.
13. Resting heart rate of 40 to 100 beats per minute (bpm).

Minimum age18 Years

Maximum age60 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

1. Has participated in previous studies of ELVN-002.
2. Underlying physical or psychological medical condition that, in the opinion of the PI, could impact on the participant’s safety, participant involvement in the study, or data integrity.
3. History or surgical records of any clinically significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary, or gastrointestinal pathology, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the IP, as determined by the PI or designee.
4. History of severe allergic or anaphylactic reactions, or sensitivity to ELVN-002, itraconazole, and phenytoin, or their constituents.
5. History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening (a general practitioner [GP] letter or biopsy report for confirmation required).
6. History of symptomatic bacterial or viral infection within 2 weeks prior to Screening.
7. Abnormal ECG findings at Screening or Day -1 (eg, repeated demonstration of a QTc interval greater than 450 ms (male) or greater than 470 ms (female) corrected by Fridericia's formula [QTcF] or Bazett's formula [QTcB]) that are considered by the PI or designee to be clinically significant.
8. History of clinically significant arrhythmia, cardiac conditions, or risk factors for Torsades de Pointes (eg, heart failure, current hypokalaemia, and family history of long QT syndrome).
9. Clinically significant findings in transthoracic echocardiogram at Screening, including less than normal left ventricular ejection fraction (LVEF).
10. Blood donation or significant blood loss (greater than 500 mL) within 60 days prior to the first administration of IP.
11. Plasma donation within 30 days prior to the first administration of IP.
12. Poor pill swallowing ability.
13. Vaccination with a live vaccine within 1 month prior to the first administration of ELVN-002.
14. Participants who do not have suitable veins for multiple venepunctures/cannulations, as assessed by the Investigator at Screening.
15. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus (HIV) antibody at Screening.
16. Known or suspected history of drug, alcohol, or other substrate abuse within 6 months prior to Screening (verbal confirmation is acceptable).
Regular alcohol consumption defined as greater than 21 units per week for males or greater than 14 units per week for females (where 1 unit equal to 285 mL of beer, 30 mL of spirit, or a 150 mL glass of wine).
17. Positive drugs of abuse screening panel (urine test including but not limited to amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, ecstasy (methylenedioxymethamphetamine [MDMA]), methadone, methamphetamines, phencyclidine, opiates, and tetrahydrocannabinol [THC]), or alcohol breath test.
18. Participant is unwilling to abstain from alcohol beginning 48 hours prior to the first administration of ELVN-002.
19. Use of IP or investigational medical device other than the ELVN-002, itraconazole, and phenytoin in this study within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest).
20. Use of (or anticipated use of) any prescription drugs or the medication leading to prolong the QT/QTc interval for 2 weeks prior to dosing, over-the-counter (OTC) medication, herbal remedies, supplements, or vitamins for 7 days prior to dosing, and during the study without prior approval of the PI and designee. Simple analgesia (paracetamol up to 4 g daily, ibuprofen or nonsteroidal anti-inflammatory drug [NSAID] up to 1200 mg daily) may be permitted at the discretion of the PI.
21. Intake of caffeine- or xanthine-containing products 48 hours before the first administration of IP.
22. Any intake of grapefruit, Seville oranges, pomelos, or other products containing the above-mentioned fruits within 7 days of the first administration of ELVN-002, itraconazole, and phenytoin.
23. Anything that the PI considers would jeopardise the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.

Additional exclusion criteria in Part C portion (DDI).
A participant in the DDI cohorts who meets any of the following exclusion criteria must be excluded:
1. History of significant hypersensitivity or idiosyncratic reaction to itraconazole and phenytoin or related drugs, as judged by the PI.
2. Only for participants in the phenytoin arm: history of seizures (excluding simple febrile seizures), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions considered clinically significant by the PI.

Trial summary

Malignant Pleural Effusion (MPE) can complicate most cancers and commonly causes disabling breathlessness and impairs quality of life. Patients who develop MPE often have an indwelling pleural catheter (IPC) inserted to drain excess fluid from their lungs, however these catheters can increase patients' risk of infection. This study aims to assess the use of regular preventative antibiotic cream on the incidence of infections for patients with MPE who have been fitted with an IPC.

Who is it for?
You may be eligible for this study if you are aged 19 years or older, you require insertion of an IPC for the control of malignant pleural effusion and you are willing to comply with the research procedures.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. The first group will be given antibiotic cream to apply around the insertion site for their catheter, together with instructions on how to care for their catheter, how to change the catheter and dressings and how to apply the antibiotic cream. The first group will be asked to apply the antibiotic cream after each catheter drain for up to 6 months. The second group will not be given antibiotic cream but will be given instructions on how to care for their catheter and how to change the catheter and dressings. Both groups will receive standard care from their treating physician throughout the study, including access to support services (e.g. direct phone line). All participants and carers will have the support and care of the respiratory unit. They will have access to the respiratory research staff via a direct phone line should any concerns arise.

It is hoped this research will demonstrate whether using preventative antibiotics prior to an infection occurring reduces the number, type and severity of infections that patients with an indwelling pleural catheter may experience. If this study does show a positive impact on the infection rate, it may be expanded to a larger number of patients with indwelling pleural catheters to improve their quality of life.

Broad Health ConditionMalignant pleural effusion

Specific Health ConditionRespiratory
Other respiratory disorders / diseases
Infection
Other infectious diseases
Cancer
Lung - Mesothelioma
Cancer
Other cancer types

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Hospital
Sir Charles Gairdner Hospital - Nedlands

Postcode
6009 - Nedlands

Anticipated date of first participant enrolment1/06/2023

Anticipated date of last participant enrolment1/03/2026

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

Key inclusion criteria

Patients who require insertion of an IPC for control of malignant pleural effusion (MPE).
°MPE is defined as an effusion in which cancer cells are identified in the fluid or pleural biopsy; or is a large exudative effusion without other causes in a patient with advanced disseminated malignancy.

Minimum age19 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. 	Age <18 yrs 
2. 	Allergy to mupirocin
3.    Ipsilateral pleural infection within past three months 
4.	Inability to consent
5. 	Inability to comply with the protocol. 

Trial summary

This study aims to assess the safety and tolerability of two new drugs in patients with extensive stage small cell lung cancer (ES SCLC). The first drug (68Ga-SSO120/68Ga-Satoreotide Trizoxetan) is used as a tumour imaging agent for patients who have tumours with specific receptors, while the second drug (177Lu-SSO110) targets and damages cancer cells with these specific receptors.

Who is it for?
You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with extensive stage small cell lung cancer and if you are going to be receiving atezolizumab maintenance therapy. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment.

Study details
All participants who choose to enrol in this study will undergo two screening scans using the new 68Ga-SSO120 imaging drug. The first scan will be to confirm eligibility to receive the 177Lu-SSO110 drug. If eligible, the first treatment dose with 177Lu-SSO110 will be scheduled at least 18 days after the 68Ga-SSO120 scan. The second scan with 68Ga-SSO120 will be taken at the end of treatment visit, which will be 6 weeks following the last dose of 177Lu-SSO110. For each scan, the 68Ga-SSO120 drug will be administered via an intravenous infusion 1 hour (40-90 minutes) before the PET/CT scan. The scans are anticipated to take 1-2 hours in total to complete. Participants who are confirmed to have somatostatin receptor 2 tumour cells based on the first screening scan will then be offered the opportunity to undergo treatment with the 177Lu-SSO110 drug. Participants who choose to enrol in the 177Lu-SSO110 arm of this study will have 177Lu-SSO110 administered via an intravenous infusion 7 days after their first or second atezolizumab maintenance therapy. Up to 3 additional 177Lu-SSO110 administration cycles will be given 6 to 9 weeks after the previous 177Lu-SSO110 administration (each within 7 days following an atezolizumab therapy). For participants with clinical benefit at the end of the 4 cycles the Investigator may request that the patient is provided with up to three additional treatments, which will be approved at the Sponsor’s discretion

It is hoped this research will demonstrate that each of the study drugs, 68Ga-SSO120 and 177Lu-SSO110 are safe and well tolerated by patients with extensive stage small cell lung cancer. If the results of this initial study are positive, a larger trial involving a greater number of patients with extensive stage small cell lung cancer may be undertaken to further determine the potential benefits of the new drugs.

Broad Health ConditionExtensive Stage Small Cell Lung Cancer

Specific Health ConditionCancer
Lung - Small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,WA,VIC

Anticipated date of first participant enrolment30/03/2023

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

1. Aged at least 18 years (inclusive at the time of informed consent).
2. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
3. Histologically or cytologically confirmed ES-SCLC.
4. Adequate organ and marrow function within 7 days of first dose of 177Lu-SSO110 as defined below:
a. absolute neutrophil count greater than or equal to 1,000/µL;
b. platelets of greater than or equal to 100,000/µL;
c. total bilirubin less than or equal to 1.5 × upper limit of normal (ULN) or less than or equal to 3.0 × ULN for participants with hereditary benign hyperbilirubinaemia;
d. AST (aspartate aminotransferase or serum glutamic oxaloacetic transaminase, SGOT) and ALT (alanine aminotransferase or serum glutamic pyruvic transaminase, SGPT) less than or equal to 3 × ULN (or less than or equal to 5 × ULN if liver metastases are present);
e. serum creatinine less than or equal to 1.5 × ULN;
f. estimated glomerular filtration rate greater than or equal to 45 mL/min/1.73 m2;
g. serum albumin greater than or equal to 30 g/L.
5. Life expectancy of >18 weeks at confirmation of eligibility, in the opinion of the Investigator.
6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin test within 72 hours before the first dose of study drug and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. Female participants <50 years old who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinising hormone and follicle stimulating hormone levels to confirm serological post-menopausal status.
7. WOCBP must agree to use a highly effective method of contraception during the study and for 90 days after the last dose of study drug. 
8. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 90 days after the last dose of study drug. All male participants must agree to not donate sperm during the study and for 90 days after the last dose of study drug.
9. Either positive 68Ga-SSO120 scan at screening (positive being a lesion concordant with a known lesion based on CT or FDG-PET/CT with uptake visually assessed as greater than the liver on 68Ga-SSO120 scan) or at the Investigator’s discretion, in the case of no/insufficient visible lesions at screening, a positive test for SST2 from archival tissue or histology report (positive being a H-score >50).
10. To receive the first dose of 177Lu-SSO110, participants must have received at least 1 and no more than 2 doses of maintenance atezolizumab after induction therapy consisting of a platinum-based agent (e.g., cisplatin/carboplatin), etoposide and atezolizumab.
11. Participants with previously treated brain metastases are eligible to participate if:
a. they are clinically and radiologically stable disease (no evidence of progression by imaging; same imaging modality [magnetic resonance imaging or CT scan]) must be used for each assessment) for at least 28 days prior to the first dose of study drug;
b. any neurologic symptoms returned to baseline;
c. no longer on steroids.
Note: Participants with a history of leptomeningeal disease may not participate even if stable clinically.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

A participant who meets any of the following exclusion criteria must be excluded from the study:
1. Any previous radioligand therapy (e.g., peptide receptor radionuclide therapy).
2. Any concurrent malignancy. Patients with a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen and participants with a prior malignancy that have shown evidence of complete remission are eligible for this study at the Investigator’s discretion.
3. Any condition that precludes the adequate performance of PET and/or CT scan.
4. History of clinically significant allergic reactions attributed to compounds of similar chemical composition to 68Ga, 177Lu, SSO110, SSO120, atezolizumab, somatostatin analogue peptides or other agents used in the study.
5. Any Grade >3 immune-related adverse event (irAE) during prior or current therapy with any immunotherapy agent(s). Previous irAEs thought not to increase participant’s risk of an investigational medicinal product-related AE, may be approved at the Investigator’s discretion, if it is determined as unlikely to put the participant at an increased risk of treatment-related toxicity and/or impact the integrity of study outcome (e.g., hypothyroidism on stable thyroxine replacement, adrenal insufficiency on stable hormone replacement therapy, diabetes on stable insulin therapy).
6. Use of immunosuppressive medication >10 mg prednisolone per day or equivalent within 14 days prior to the first dose of 177Lu-SSO110.
Note: Use of immunosuppressive medications as prophylaxis in participants with contrast allergies are acceptable. In addition, temporary uses of corticosteroids considered non-clinically relevant may be approved at the Investigator’s discretion.
7. Any unresolved AEs Grade >1 from prior anticancer therapy except for alopecia. Participants with residual AEs Grade >1 considered unlikely to put the participant at an increased risk of treatment-related toxicity and/or impact the integrity of study outcome may be permitted on a case-by-case basis at the Investigator’s discretion (e.g., thyroid disorders or cortisol insufficiency on stable hormone replacement therapy).
8. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s); active bacterial, fungal, or viral infections requiring systemic therapy.
9. Live vaccine administration less than or equal to 21 days prior to the first dose of study drug.
10. Active or previous autoimmune diseases, with the following exemptions:
a. Hashimoto’s thyroiditis on stable thyroid replacement therapy;
b. Type 1 diabetes mellitus on stable insulin therapy;
c. Other autoimmune disorders not considered to put participant at a higher risk of irAE may be approved at the Investigator’s discretion.
11. History of primary immunodeficiency, bone marrow (BM) transplantation, or solid organ transplantation.
12. History of inflammatory bowel disease, interstitial lung disease (pneumonitis), myocarditis, Stevens-Johnson syndrome, or toxic epidermal necrolysis.
13. History of known alcohol or substance abuse and/or a known psychiatric illness/social situation that would limit compliance with study requirements.
14. Has had or is scheduled to have major surgery <28 days prior to the first dose of study drug.
15. Known active human immunodeficiency virus or known active hepatitis B or C virus.
16. Known history within 4 months prior to first dose of study treatment or current symptomatic heart failure as per New York Heart Association classes III-IV, unstable angina, myocardial infarction, serious/uncontrolled/unstable cardiac arrhythmia, cerebral vascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism.
17. Known history of severe asthma and/or chronic obstructive airways disease requiring systemic steroid therapy within 6 months prior to first dose of study treatment. Baseline oxygen saturation reading at room air must be >90% by pulse oximetry.
18. Known history of severe eczema and other skin/pruritic conditions requiring systemic steroid therapy within 6 months prior to first dose of study treatment.
19. Any extensive radiotherapy less than or equal to 3 months before first 177Lu-SSO110 administration, defined as external beam radiation (e.g., stereotactic ablative radiotherapy) to >25% of the BM or brachytherapy.
20. A known superscan indicating extensive bony metastatic disease.
21. Received anticancer therapy (other than atezolizumab), including chemotherapy, immunotherapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 18 days (or 5 half-lives for biologic/non-cytotoxic agents, whichever is shorter), prior to the first dose of the study drug.

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 goal of this study is to undertake rigorous scientific evaluation of the most popular Australian high-quality smoking cessation app.  Screen2Quit (formally known as My QuitBuddy) in current smokers scheduled to undergo lung cancer screening.
Who is it for?
You may be eligible for this study if you are aged 55 years and over, you currently smoke, and you are eligible for lung cancer screening.
Study details
Participants will be randomised (i.e. allocated by chance) to either receive access to the Screen2Quit app, or will be directed to a tailored smoking cessation resources webpage. Participants in the Screen2Quit group will be sent a link to download the app to their phone, through which users may enter their planned quit date, smoking history, and set goals for quitting smoking. The app sends daily reminders and provides daily updates on health benefits of quitting, money saved, can be tailored to interact with the participant at self-identified "danger times" for smoking. Each participant’s use of the app will be determined through questionnaires and by accessing app analytics. Participants who do not receive access to the app will be directed to an online resource according to their jurisdiction (e.g. Queensland participants will be directed to the Qld government smoking cessation website QuitHQ). Participants will be instructed to use the app/web page resources ad lib in conjunction with whichever standard smoking cessation therapies are recommended by their treating health team (e.g. Quitline counselling, pharmacotherapy). All participants will be followed-up for 12 months post-enrolment to assess their self-reported quit rate, biochemically verified abstinence from smoking using a urine test, quit attempts, motivation, and use of counselling/pharmacotherapy.

It is hoped that this study may show that the Screen2Quit app, when used with usual care, increases quit rates compared to usual care alone in smokers undergoing lung cancer screening.

Broad Health Conditionnicotine addiction
Lung cancer screening

Specific Health ConditionMental Health
Addiction
Public Health
Health promotion/education
Respiratory
Other respiratory disorders / diseases
Cancer
Lung - Non small cell
Cancer
Lung - Small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,WA,VIC

Hospital
The Prince Charles Hospital - Chermside

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Royal Melbourne Hospital - City campus - Parkville

Hospital
Epworth Eastern Hospital - Box Hill

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
Fiona Stanley Hospital - Murdoch

Postcode
4032 - Chermside

Postcode
2010 - Darlinghurst

Postcode
3050 - Parkville

Postcode
3128 - Box Hill

Postcode
6009 - Nedlands

Postcode
6150 - Murdoch

Trial location outside Australia

Country
Canada

State
British Columbia

Anticipated date of first participant enrolment1/05/2023

Anticipated date of last participant enrolment31/12/2026

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Adults smokers who are eligible for lung cancer screening and are able to give informed consent, own a smartphone and a computer, are capable of downloading an app and have access to the internet

Minimum age50 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Those who do not own a smartphone and/or do not have access to the internet.  Smokers who are current users of a smoking cessation smartphone app.

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

Hospital
Port Macquarie Base Hospital - Port Macquarie

Hospital
The Queen Elizabeth Hospital - Woodville

Hospital
Royal Hobart Hospital - Hobart

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

Postcode
2444 - Port Macquarie

Postcode
5011 - Woodville South

Postcode
7000 - Hobart

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 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

Hospital
GenesisCare - St. Vincent's Melbourne - Fitzroy

Postcode
2145 - Westmead

Postcode
3084 - Heidelberg

Postcode
2170 - Liverpool

Postcode
2148 - Blacktown

Postcode
4029 - Herston

Postcode
4102 - Woolloongabba

Postcode
3065 - Fitzroy

Anticipated date of first participant enrolment4/01/2022

Anticipated date of last participant enrolment30/09/2027

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

- Provided written informed consent
- Histologically or cytologically documented ES-ECLC
- Thoracic disease deemed suitable for radiation therapy following initial systemic therapy
- If brain metastases present, then they are to be;
     a. asymptomatic without steroid therapy may be included or
     b. have required treatment (radiotherapy and/or surgery) and are clinically stable and patient is on a stable or reducing steroid dose of no more than dexamethasone 4mg/day (or equivalent)
- Patients must be considered suitable to receive platinum-based chemotherapy regimen as first-line treatment for ES-SCLC
- ECOG performance-status score of 0 or 1 at registration
- Life expectancy greater than or equal to 12 weeks at registration
- Body weight > 30 kg
- 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
- Adequate organ and marrow function as defined in the Protocol
- Female patients who;
     a. are willing to use adequate contraceptive measures until 90 days after the final dose of trial treatment
     b. are not breast feeding
     c. have a negative pregnancy test prior at registration if of child bearing potential or have evidence of non-child bearing potential by fulfilling the criteria as stated in the Protocol at screening

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

- Treatment with any of the following:
     a. Concurrent chemotherapy (not relevant to patients registered prior to cycle 2who will have received a cycle of platinum/etoposide chemotherapy),investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
     b. An investigational product during the last 4 weeks
     c. High dose radiotherapy to the chest prior to systemic therapy precluding further thoracic radiation therapy. Radiation therapy outside of the chest for palliative care (i.e., bone metastasis) is allowed but must be completed before first dose of the trial medication
     d. Immunosuppressive medication within 14 days before the first dose of Durvalumab. Some exceptions apply
     e. Live, attenuated vaccine within 30 days prior to the first dose of Durvalumab
     f. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Durvalumab. Surgical procedures to obtain a lung cancer diagnosis or for palliation are allowed
- Medical contraindication to, known allergy or hypersensitivity to Durvalumab, etoposide, carboplatin (patients with allergy/hypersensitivity to carboplatin may receive cisplatin), cisplatin, or any of their excipients
- History of allogeneic organ transplantation
- Has a para-neoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS. Patients with hyponatraemia considered due to SIADH syndrome are eligible
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis. Some exceptions apply
- Interstitial lung disease/pulmonary fibrosis. Patients with emphysema and associated limited areas of pulmonary fibrosis are eligible
- Uncontrolled intercurrent illness
- History of another primary malignancy. Some exceptions apply
- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of Durvalumab

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 study is to look at the efficacy and safety of VGT-309, a tumour targeted imaging agent, when used intra-operatively in subjects with scheduled surgical resection or biopsy of suspicious or proven lung cancer

Who is it for?
You may be eligible for this study if you are an adult man or woman at least 18 years of age and you are scheduled to undergo surgical resection or excisional biopsy (per standard of care) of a lung nodule that is suspicious for, or proven to be, lung cancer. 

Study details
If you meet the entry criteria you will be assigned to one of two dosing cohorts and will receive a single dose of VGT-309 which will be given to you as in intravenous infusion over a period of 15 to 20 minutes either 12-36 hours before your surgery or 2-6 hours before your surgery.  Total participation will last about 35 days (not including the 28 day screening period) and during this time for safety you will have blood and urine samples drawn, your vital signs will be checked, you will have physical examinations and ECGs will be conducted.

It is hoped this research will enable doctors in the future to use VGT-309 as an intraoperative fluorescent imaging agent to identify lung cancer compared to surrounding normal tissue

Broad Health ConditionLung Cancer

Specific Health ConditionCancer
Lung - Non small cell

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

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

Hospital
St Vincent's Private Hospital - Fitzroy

Hospital
Royal Melbourne Hospital - Royal Park campus - Parkville

Postcode
3065 - Fitzroy

Postcode
3052 - Parkville

Anticipated date of first participant enrolment11/05/2021

Anticipated date of last participant enrolment12/09/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

1. Be willing and able to sign the informed consent and comply with study procedures
2. Be at least 18 years of age
3. Be scheduled to undergo planned standard of care surgical resection for a lung nodule or mass, whether or not it is biopsy-proven
4. Have an ECOG score of 0-1
5. Have an acceptable hematologic and coagulation status and kidney and liver functions at study entry 
6. Be male or female and meet the following conditions:
a. Female participants must be of non-childbearing potential, or,
b. If of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through Day 30.
c. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 90 days post-dose and agree not to donate semen during this waiting period.
d.	Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
- Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
- Intrauterine device or intrauterine hormone-releasing system
NOTE: Participants who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above. They are required to maintain abstinence from screening through Day 30.
7. Are judged to be an acceptable surgical risk by the operating surgeon and the anesthesiologist/anesthetist.
8. Have not participated in a clinical trial within the last 30 days.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Have a history of myocardial infarction, cerebrovascular accident, uncontrolled congestive heart failure, significant liver disease, or unstable angina within 6 months prior to enrollment.
2. Have any other condition that causes the Investigator to deem them unfit for lung resection.
3. Are receiving a Class IA (i.e. quinidine, procainamide) or Class III (i.e. dofetilide, amiodarone, sotalol) antiarrhythmic agents
4. Have congenital long QT syndrome or QTcF > 450 ms (males) or >470 ms (females) by history or at Screening ECG.
5. Have a history or evidence of interstitial pneumonitis or pulmonary fibrosis
6. A known allergy or reaction to ICG or other radiographic contrast agents 
7. Any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study

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 enrolment30/06/2023

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.