Lung Cancer Stage IVLU-NGS-2NCT03558165
Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay
An observational study of Lung Cancer Stage IV, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Stage IV
- What is being tested?
- Oncomine Comprehensive Assay
- Type of treatment
- Injection or infusion
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 18 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be recruited at outpatient thoracic oncology clinics at the Princess Margaret Cancer Centre.
Who may be able to join
- 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
Who cannot join
- ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Cancer Stage IV
- Being tested
- Oncomine Comprehensive Assay
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncomine Comprehensive AssayDiagnostic test
Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay
| Study group | Role | What they receive |
|---|---|---|
| Stage IV Lung Adenocarcinoma | Not described Receives: Diagnostic Test: Oncomine Comprehensive Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 1 year from Oncomine Comprehensive Assay testing
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Mar 2018
- Primary completion20 Aug 2020
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, The Princess Margaret Cancer Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558165
- Sponsor's protocol ID
- 17-5638
- Acronym
- LU-NGS-2
- Status last verified
- May 2022
- First submitted
- 7 May 2018
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35278845
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel
- ClinicalTrials.gov ID
- NCT03558165
- Acronym / sponsor ID
- LU-NGS-2 / 17-5638
- Conditions
- Lung Cancer Stage IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, The Princess Margaret Cancer Foundation
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage IV Lung Adenocarcinoma | – | Diagnostic Test: Oncomine Comprehensive Assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be recruited at outpatient thoracic oncology clinics at the Princess Margaret Cancer Centre.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncomine Comprehensive AssayStage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay | Diagnostic test | Stage IV Lung Adenocarcinoma |
Primary outcome
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.
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).
3 secondary outcomes
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).
Financial feasibility
Time frame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 35278845Perdrizet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Stage IV, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental actionable targets (time frame: 8-12 weeks from Oncomine Comprehensive Assay testing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.