Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2022

ASPiRATION: An Australian observational cohort study to assess the clinical impact of comprehensive genomic profiling in metastatic lung cancer patients. Protocol number TOGA 19/003. (#453)

Nick Pavlakis 1 , David Thomas 2 3 , Chee K Lee 4 5 , Antony J Mersiades 4 , Mandy Ballinger 2 , Emily Collignon 2 , Michelle M Cummins 4 , Lucille Sebastian 4 , Sonia Yip 4 , Rachael Morton 4 , Chris Brown 4 , R. John Simes 4 , Benjamin J Solomon 6
  1. Department of Medical Oncology, Royal North Shore Hospital, St Leonards, NSW, Australia
  2. Garvan Institute of Medical Research, Sydney, NSW, Australia
  3. Omico, Sydney, NSW, Australia
  4. NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW, Australia
  5. Department of Medical Oncology, St George Hospital, Sydney, NSW, Australia
  6. Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia

Background

Non-squamous metastatic non-small cell lung cancer (mNSCLC) is a heterogeneous disease with a wide diversity of mutations, alterations or abnormal gene expression responsible for cell growth and metastasis. Targeted treatments can improve clinical outcomes, however these are not adequately identified by standard of care (SoC) testing, which commonly use single gene assays or “hot-spot” panels. Comprehensive genomic profiling (CGP) can identify more actionable genomic alterations, enabling more patients to receive timely targeted treatment.  The study investigates the clinical impact of CGP on the management of mNSCLC and assess feasibility of upfront CGP implementation nationally.

 

Methods

Australia-wide multi-centre prospective observational cohort study involving 17 participating hospitals, recruiting 1,000 newly diagnosed mNSCLC patients with adequate tumor tissue for CGP and SoC testing. Two cycles of standard treatment are allowed while awaiting CGP results. Patients with targetable alterations may be eligible for associated substudies, clinical trials or access programs.  

 

Primary outcomes: impact of CGP (% patients with actionable genomic alterations with CGP vs SoC testing; % patients receiving targeted therapy; and feasibility of CGP (time to results; % patients requiring treatment prior to results; % patients requiring repeat biopsy for CGP).

 

Secondary outcomes: % patients with change in treatment recommendation; % patients participating in clinical trials; clinical outcomes; healthcare resource use and costs; health-related quality of life; and cost-effectiveness of CGP. Correlative studies will explore potential prognostic biomarkers of clinical benefit of targeted therapies.

 

ASPiRATION is a collaboration between TOGA, NHMRC Clinical Trials Centre, University of Sydney, Omico and Garvan Institute of Medical Research. Support is from Australian government Medical Research Future Fund (MRFF application EPCD000005) and Roche Products Pty Limited (Australia). ANZ Clinical Trials Registry: ANZCTRN12621000221853.

 

Interim results

At 31 July 2022, 534 participants had been enrolled. The number of genomic alterations of interest identified to date will be presented.