Clinical Trials

19/003 ASPiRATION

An observational cohort study to assess the clinical impact of CGP in metastatic lung cancer patients.

Recruitment target:
1000
Status:
Completed
(Recruitment complete)

Summary:

An observational cohort study to assess the clinical impact of CGP in metastatic lung cancer patients.

The ASPiRATION study is investigating the clinical impact of comprehensive genomic profiling (CGP) on the management of metastatic NSCLC and assessing the feasibility of CGP implementation nationally. When the ASPiRATION study was open to recruitment, standard of care tumour testing for NSCLC patients could only identify changes in three genes: EGFR, ALK & ROS1. Patients enrolled on the ASPiRATION study also had their tumour tested using CGP, often referred to as molecular screening and/or profiling. This technique allows treating clinicians to look at changes in hundreds of genes in a single test. After a patient’s tumour was tested, a report was 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.

It is hoped this research will determine whether additional molecular screening can be feasibly integrated into Australian clinical practice for patients with metastatic NSCLC.

The ASPiRATION study is led by TOGA, in collaboration with Omico (Australian Genomic Cancer Medicine Centre) and the NHMRC Clinical Trials Centre (CTC).

Clinical trial design:

Observational cohort study

Indication:

Newly-diagnosed metastatic non-squamous non small cell lung cancer (NSCLC)

Intervention:

Comprehensive genomic profiling to identify actionable biomarkers to guide therapy

ASPiRATION substudies include NSCLC-specific substudies and Omico MoST substudies that cater for NSCLC patients with tumours expressing the appropriate molecular biomarkers. The ASPiRATION substudies are all Phase II single arm open label signal-seeking clinical trials with the intent to demonstrate or confirm drug activity and safety in order to inform subsequent randomised Phase III clinical trials.

The ASPiRATION study and substudies are led by TOGA, in collaboration with Omico (Australian Genomic Cancer Medicine Centre) and the NHMRC Clinical Trials Centre (CTC), University of Sydney.

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