Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Plain-language summary

This study examines a next-generation sequencing test called the Oncomine Comprehensive Assay to identify genetic changes in tumor tissue of patients with advanced lung adenocarcinoma. Eligible patients are 18 years or older, have stage IV lung adenocarcinoma and are candidates for targeted therapy. It was conducted as a study without a formal phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

University Health Network, Toronto

Intervention

Oncomine Comprehensive Assay

Start date

3/1/2018

Estimated completion

2/18/2022

Countries

Canada

Related genes

Locations

• Toronto, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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