Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Completed

• Conditions: Lung Cancer Stage IV
• Interventions: Diagnostic Test: Oncomine Comprehensive Assay

• Registration Number: NCT03558165
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Primary Completion: 2020-08-20
• Study Completion: 2022-02-18
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage IV Lung Adenocarcinoma	Oncomine Comprehensive Assay	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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).

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada