Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Study Overview
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Brief Summary
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Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes. This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.

Official Title
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Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel

Conditions
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Lung Cancer Stage IV

Intervention / Treatment
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* Diagnostic Test: Oncomine Comprehensive Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years of age Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted) Stage IV disease Sufficient FFPE tumour tissue for OCCP testing Performance status 0-2 Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist Prognosis > 6 months Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed Exclusion Criteria: ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage IV Lung Adenocarcinoma<br> | Diagnostic Test: Oncomine Comprehensive Assay<br>* Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental actionable targets | Calculate the number of incremental actionable targets identified by the Oncomine Comprehensive Assay compared to current standard of care molecular profiling (EGFR, ALK) in patients with stage IV NSCLC. | 8-12 weeks from Oncomine Comprehensive Assay testing | 
| Number of clinical trial opportunities | Compile the number of clinical trial opportunities that patients with stage IV NSCLC would be eligible for based on targets identified by the Oncomine Comprehensive Assay compared to standard of care molecular profiling (EGFR, ALK). | 1 year from Oncomine Comprehensive Assay testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test turnaround time | Calculate the time to receive Oncomine Comprehensive Assay results compared to the standard of care tissue molecular test turnaround time (EGFR, ALK). | To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). | 
| Financial feasibility | Perform a cost consequence analysis to evaluate financial feasibility of the Oncomine Comprehensive Assay. | To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). | 
| Patient willingness-to-pay | Evaluate patient willingness-to-pay for using a next generation sequencing assay, like the Oncomine Comprehensive Assay, using a validated patient survey. | To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). |