Lung Cancer Stage IV
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTOncomine Comprehensive Assay
Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay
Sponsors
Princess Margaret Hospital, Canada
The Princess Margaret Cancer Foundation
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental actionable targets | 8-12 weeks from Oncomine Comprehensive Assay testing | 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. |
| Number of clinical trial opportunities | 1 year from Oncomine Comprehensive Assay testing | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test turnaround time | To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). | Calculate the time to receive Oncomine Comprehensive Assay results compared to the standard of care tissue molecular test turnaround time (EGFR, ALK). |
| Financial feasibility | To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). | Perform a cost consequence analysis to evaluate financial feasibility of the Oncomine Comprehensive Assay. |
| Patient willingness-to-pay | To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). | Evaluate patient willingness-to-pay for using a next generation sequencing assay, like the Oncomine Comprehensive Assay, using a validated patient survey. |
Countries
Canada
Outcome results
None listed