Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

University Health Network, Toronto134 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

134

Conditions

Lung Cancer Stage IV

Interventions

Oncomine Comprehensive AssayDIAGNOSTIC_TEST

Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 1 year from Oncomine Comprehensive Assay testing

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).

Data from ClinicalTrials.gov

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