Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Lung Cancer Stage IV Clinical Trial

— LU-NGS-2  

Official title:

Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558165
• Other study ID #: 17-5638
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: February 18, 2022

Study information

• Verified date: May 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 18, 2022
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Lung Cancer Stage IV
• Lung Neoplasms

Intervention

Diagnostic Test:
• Oncomine Comprehensive Assay
Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Cancer Foundation, Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).
Secondary	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).
Secondary	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).