Clinical trial NCT03558165: Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay
Official title: Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Stage IV
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: The Princess Margaret Cancer Foundation
First posted: 2018-06-15
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be recruited at outpatient thoracic oncology clinics at the Princess Margaret Cancer Centre.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incremental actionable targets
timeFrame: 8-12 weeks from Oncomine Comprehensive Assay testing
measure: Number of clinical trial opportunities
timeFrame: 1 year from Oncomine Comprehensive Assay testing
Secondary outcomes:
measure: Test turnaround time
timeFrame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
measure: Financial feasibility
timeFrame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
measure: Patient willingness-to-pay
timeFrame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
citation: 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.