Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay (LU-NGS-2)

University Health Network, Toronto

Status: Completed

Conditions: Lung Cancer Stage IV

Treatments: Diagnostic Test: Oncomine Comprehensive Assay

Study type: Observational

Funder types: Other

Identifiers

NCT03558165

17-5638

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

134 participants in 1 patient group

Stage IV Lung Adenocarcinoma

Treatment:

Diagnostic Test: Oncomine Comprehensive Assay