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

Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel

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 Overview

• Status: Completed
• Conditions: Lung Cancer Stage IV
• Intervention / Treatment: Diagnostic test: Oncomine Comprehensive Assay

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be recruited at outpatient thoracic oncology clinics at the Princess Margaret Cancer Centre.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage IV Lung Adenocarcinoma	Diagnostic test: Oncomine Comprehensive Assay; Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	1 year from Oncomine Comprehensive Assay testing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada; The Princess Margaret Cancer Foundation

Publications and helpful links

General Publications

• Perdrizet K, Stockley TL, Law JH, Smith A, Zhang T, Fernandes R, Shabir M, Sabatini P, Youssef NA, Ishu C, Li JJ, Tsao MS, Pal P, Cabanero M, Schwock J, Ko HM, Boerner S, Ruff H, Shepherd FA, Bradbury PA, Liu G, Sacher AG, Leighl NB. Integrating comprehensive genomic sequencing of non-small cell lung cancer into a public healthcare system. Cancer Treat Res Commun. 2022;31:100534. doi: 10.1016/j.ctarc.2022.100534. Epub 2022 Feb 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 17-5638

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No