NCT03558165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

May 7, 2018

Last Update Submit

May 16, 2022

Conditions

Lung Cancer Stage IV

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Test turnaround time

    To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).

  • Financial feasibility

    To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).

  • Patient willingness-to-pay

    To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).

Study Arms (1)

Stage IV Lung Adenocarcinoma

Diagnostic Test: Oncomine Comprehensive Assay

Interventions

Oncomine Comprehensive AssayDIAGNOSTIC_TEST

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

Stage IV Lung Adenocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35278845DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 15, 2018

Study Start

March 1, 2018

Primary Completion

August 20, 2020

Study Completion

February 18, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

CA(1)