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Completed

NCT Number: NCT03558165

Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

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.

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Key information

Conditions

Lung Cancer Stage IV Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oncomine Comprehensive Assay

Diagnostic Test

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

Primary outcomes

  1. Incremental actionable targets

    Time frame: 8-12 weeks from Oncomine Comprehensive Assay testing

    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.

  2. Number of clinical trial opportunities

    Time frame: 1 year from Oncomine Comprehensive Assay testing

    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).

Secondary outcomes

  1. Test turnaround time

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

    Calculate the time to receive Oncomine Comprehensive Assay results compared to the standard of care tissue molecular test turnaround time (EGFR, ALK).

  2. Financial feasibility

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

    Perform a cost consequence analysis to evaluate financial feasibility of the Oncomine Comprehensive Assay.

  3. Patient willingness-to-pay

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

    Evaluate patient willingness-to-pay for using a next generation sequencing assay, like the Oncomine Comprehensive Assay, using a validated patient survey.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada
  • The Princess Margaret Cancer Foundation

Registry information

Official study title

Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel

Acronym: LU-NGS-2

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jun 15, 2018
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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