Australian Clinical Trials

Broad Health Condition Cancer

Specific Health ConditionLung - Non small cell

Trial Focus

Recruitment Details

Recruitment status
Recruiting

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

Hospital
Linear Clinical Research - Nedlands
The Royal Adelaide Hospital - Adelaide
Peter MacCallum Cancer Centre - Melbourne
Princess Alexandra Hospital - Woolloongabba
Royal Hobart Hospital - Hobart
Westmead Hospital - Westmead
Royal North Shore Hospital - St Leonards
The Prince Charles Hospital - Chermside
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Flinders Medical Centre - Bedford Park
Royal Darwin Hospital - Tiwi
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
The Alfred - Melbourne
Chris O’Brien Lifehouse - Camperdown
The Canberra Hospital - Garran
Austin Health - Austin Hospital - Heidelberg
Border Medical Oncology - Albury

Postcode
6009 - Nedlands
5000 - Adelaide
3000 - Melbourne
4102 - Woolloongabba
7000 - Hobart
2145 - Westmead
2065 - St Leonards
4032 - Chermside
2010 - Darlinghurst
5042 - Bedford Park
0810 - Tiwi
3065 - Fitzroy
2050 - Camperdown
2605 - Garran
3084 - Heidelberg
2640 - Albury

Anticipated date of last participant enrolment31/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Trial summary

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

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

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