Non-small Cell Lung CancerVALUENCT03576937
Achieving Value in Cancer Diagnostics: Blood Versus Tissue Molecular Profiling - a Prospective Canadian Study
An observational study of Non-small Cell Lung Cancer, run by University Health Network, Toronto at 6 sites in Canada.
Trial summary
Current guidelines in non-small cell lung cancer recommend genomic assessment for mutations in EGFR and BRAF, gene rearrangements in ALK and ROS1, and resistance mutations such as T790M upon progression during EGFR inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- GUARDANT360
- Type of treatment
- Injection or infusion
- How many people
- 207 participants
- Where
- 6 sitesCanada
- Study dates
- 12 Feb 2019to 30 Apr 2023
- 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: Non-small cell lung cancer patients (Stage IIIB or IV not eligible for curative intent treatment, or relapsed/recurrent disease)
Who may be able to join
- Patients with non-small cell lung cancer (NSCLC) with:
- Histologically-proven, advanced (Stage IIIB or IV not eligible for curative intent treatment, or relapsed/recurrent) disease;
- Non-squamous histology (mixed adenocarcinoma histology is allowed);
- Never smoking or light smoking history (≤10 pack years);
- Measureable disease by RECIST 1.1;
- Patients who have previously received curative therapy are eligible if primary treatment was completed at least 6 months prior to the development of advanced disease; for patients who received adjuvant systemic therapy, the last dose of treatment must have been given at least 6 weeks prior to enrollment;
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- Age ≥ 18 years;
- Ability to provide written informed consent;
- Agreement to provide blood sample prior to starting systemic treatment;
- Eligibility for targeted therapy in the opinion of the investigator;
- Standard-of-care tissue genotyping ordered or planned. Patients with tissue deemed insufficient for genotyping are eligible.
- Cohort 2 only: evidence of disease progression on prior targeted tyrosine kinase inhibitor or other targeted therapy for EGFR including T790M, ALK, ROS-1 or BRAF-deranged advanced NSCLC. Patients progressing on 1st or 2nd generation EGFR TKI must have undergone SOC testing for EGFR T790M. If blood- or tissue-negative for T790M, the patient is eligible for this study. If T790M-positive, the patient must have progressed on a T790M inhibitor to be eligible. Intervening systemic therapy such as chemotherapy or immunotherapy is permitted.
Who cannot join
- Pregnancy;
- ≥10 pack year smoking history;
- Any other concurrent malignancy except for localized, non-melanoma, cutaneous cancer or non-invasive cervical cancer. Any prior cancer other than NSCLC must have occurred more than 2 years prior to study entry with no evidence of currently active disease;
- Prior resection of metastatic disease if the resected metastasis was the only site of measurable disease;
- Radiation of a metastatic lesion or residual disease if administered to the only site(s) of advanced disease;
- Cohort 1 only: Prior systemic treatment for metastatic NSCLC including but not limited to targeted therapy, chemotherapy, immunotherapy, or biologic therapy. Adjuvant therapy is permitted at least 6 weeks prior to enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Tom Baker Cancer Centre
Calgary, Alberta
Juravinski Cancer Centre
Hamilton, Ontario
Jewish General Hospital
Montreal, Quebec
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario
BC Cancer Agency
Vancouver, British Columbia
About this study
Current guidelines in non-small cell lung cancer recommend genomic assessment for mutations in EGFR and BRAF, gene rearrangements in ALK and ROS1, and resistance mutations such as T790M upon progression during EGFR inhibitor therapy. However, obtaining sufficient tumour tissue to test for these molecular alterations, as well as those with emerging targeted therapies, is challenging in lung cancer. A promising method to improve molecular diagnostic testing in lung and other cancers is the use of circulating cell-free DNA (cfDNA) obtained from blood samples or liquid biopsies. This multi-centre prospective study will compare blood-based profiling (using the GUARDANT360 assay) to standard of care tissue-based profiling within the Canadian system.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- GUARDANT360
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUARDANT360Diagnostic test
GUARDANT360 is a validated cfDNA next-generation sequencing assay that identifies variants in 73 genes associated with several cancers.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with advanced (incurable stage IIIB or IV), histologically proven, non-squamous NSCLC who are never- or light-smokers (≤10 pack year smoking history) and are being considered for systemic therapy in the first line setting are eligible. Blood will be collected prior to first line treatment for testing cfDNA with the GUARDANT360 assay. Testing of available diagnostic tissue for genomic abnormalities will be performed in all patients per standard of care at the participating sites. Receives: Diagnostic Test: GUARDANT360 | |
| Cohort 2 | Patients with advanced non-squamous NSCLC with known oncogenic drivers (such as EGFR, ALK, ROS-1, BRAF) that have failed tyrosine kinase inhibitor (TKI) therapy, and are being considered for subsequent therapy. Blood will be collected from patients at time of progression on TKI therapy for cfDNA testing with the GUARDANT360 assay. Testing of available diagnostic tissue for genomic abnormalities will be performed in all patients per standard of care at the participating sites. Receives: Diagnostic Test: GUARDANT360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate to first-line therapy
Measure best response to first-line therapy using investigator-assessed RECIST 1.1, including progression free survival and time to treatment failure, in patients with advanced lung adenocarcinoma using the cfDNA GUARDANT360 assay versus standard of care tissue genotyping.
Measured: Up to 18 Months
Secondary outcomes (5)
Proportion of patients receiving targeted therapy
Compare the proportion of patients receiving targeted therapy using the cfDNA GUARDANT360 assay versus standard of care tissue genotyping.
Measured: Up to 18 Months
Time to Treatment Initiation
The time to treatment initiation using both genotyping methods, will be calculated as the number of days from the date of pathologic or clinical stage IV NSCLC diagnosis until initiation of systemic treatment. This will be compared to the turnaround time for GUARDANT360 results.
Measured: Up to 18 Months
Incremental number of actionable genomic alterations
Count the number of actionable genomic alterations identified in cfDNA that were not identified in tumour tissue standard of care testing.
Measured: Up to 18 Months
Turnaround time of cfDNA vs. tissue results
Calculate the time (in days) from the date of request for testing to the report date for both genotyping methods.
Measured: Up to 18 Months
Costs of cfDNA vs. tissue testing
Cost consequence analysis to examine incremental mean direct and indirect costs in Canadian dollars between the two approaches (cfDNA testing vs tumour tissue genotyping).
Measured: Up to 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start12 Feb 2019
- Primary completion30 Oct 2020
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576937
- Sponsor's protocol ID
- 18-5353
- Acronym
- VALUE
- Status last verified
- May 2023
- First submitted
- 22 Jun 2018
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Value in Cancer Diagnostics: Blood Versus Tissue Molecular Profiling - a Prospective Canadian Study
- ClinicalTrials.gov ID
- NCT03576937
- Acronym / sponsor ID
- VALUE / 18-5353
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 5 Jul 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.
Current guidelines in non-small cell lung cancer recommend genomic assessment for mutations in EGFR and BRAF, gene rearrangements in ALK and ROS1, and resistance mutations such as T790M upon progression during EGFR inhibitor therapy. However, obtaining sufficient tumour tissue to test for these molecular alterations, as well as those with emerging targeted therapies, is challenging in lung cancer. A promising method to improve molecular diagnostic testing in lung and other cancers is the use of circulating cell-free DNA (cfDNA) obtained from blood samples or liquid biopsies. This multi-centre prospective study will compare blood-based profiling (using the GUARDANT360 assay) to standard of care tissue-based profiling within the Canadian system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: GUARDANT360Patients with advanced (incurable stage IIIB or IV), histologically proven, non-squamous NSCLC who are never- or light-smokers (≤10 pack year smoking history) and are being considered for systemic therapy in the first line setting are eligible. Blood will be collected prior to first line treatment for testing cfDNA with the GUARDANT360 assay. Testing of available diagnostic tissue for genomic abnormalities will be performed in all patients per standard of care at the participating sites. |
| Cohort 2 | – | Diagnostic Test: GUARDANT360Patients with advanced non-squamous NSCLC with known oncogenic drivers (such as EGFR, ALK, ROS-1, BRAF) that have failed tyrosine kinase inhibitor (TKI) therapy, and are being considered for subsequent therapy. Blood will be collected from patients at time of progression on TKI therapy for cfDNA testing with the GUARDANT360 assay. Testing of available diagnostic tissue for genomic abnormalities will be performed in all patients per standard of care at the participating sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-small cell lung cancer patients (Stage IIIB or IV not eligible for curative intent treatment, or relapsed/recurrent disease)
Key inclusion criteria (12 listed)
- Histologically-proven, advanced (Stage IIIB or IV not eligible for curative intent treatment, or relapsed/recurrent) disease;
- Non-squamous histology (mixed adenocarcinoma histology is allowed);
- Never smoking or light smoking history (≤10 pack years);
- Measureable disease by RECIST 1.1;
- Patients who have previously received curative therapy are eligible if primary treatment was completed at least 6 months prior to the development of advanced disease; for patients who received adjuvant systemic therapy, the last dose of treatment must have been given at least 6 weeks prior to enrollment;
Key exclusion criteria (6 listed)
- Pregnancy;
- ≥10 pack year smoking history;
- Any other concurrent malignancy except for localized, non-melanoma, cutaneous cancer or non-invasive cervical cancer. Any prior cancer other than NSCLC must have occurred more than 2 years prior to study entry with no evidence of currently active disease;
- Prior resection of metastatic disease if the resected metastasis was the only site of measurable disease;
- Radiation of a metastatic lesion or residual disease if administered to the only site(s) of advanced disease;
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 |
|---|---|---|
| GUARDANT360GUARDANT360 is a validated cfDNA next-generation sequencing assay that identifies variants in 73 genes associated with several cancers. | Diagnostic test | Cohort 1, Cohort 2 |
Primary outcome
Response rate to first-line therapy
Time frame: Up to 18 Months
Measure best response to first-line therapy using investigator-assessed RECIST 1.1, including progression free survival and time to treatment failure, in patients with advanced lung adenocarcinoma using the cfDNA GUARDANT360 assay versus standard of care tissue genotyping.
5 secondary outcomes
Proportion of patients receiving targeted therapy
Time frame: Up to 18 Months
Time to Treatment Initiation
Time frame: Up to 18 Months
Incremental number of actionable genomic alterations
Time frame: Up to 18 Months
Turnaround time of cfDNA vs. tissue results
Time frame: Up to 18 Months
Costs of cfDNA vs. tissue testing
Time frame: Up to 18 Months
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 15 May 2023.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by University Health Network, Toronto at 6 sites 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 12 inclusion and 6 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 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Response rate to first-line therapy (time frame: Up to 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2023.