Achieving Value in Cancer Diagnostics: Blood Versus Tissue Molecular Profiling - a Prospective Canadian Study

Plain-language summary

This study compares a blood-based test (GUARDANT360) with tissue-based testing to identify genetic changes in patients with non-small cell lung cancer. Eligible patients have advanced, non-squamous disease, a never- or light-smoking history and are candidates for targeted therapy. It was conducted as a study without a formal phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

University Health Network, Toronto

Intervention

GUARDANT360

Start date

2/12/2019

Estimated completion

4/30/2023

Countries

Canada

Related genes

Locations

• Calgary, Canada
• Vancouver, Canada
• Hamilton, Canada
• Ottawa, Canada
• Toronto, Canada
• Montreal, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

Patients with non-small cell lung cancer (NSCLC) with:

1. Histologically-proven, advanced (Stage IIIB or IV not eligible for curative intent treatment, or relapsed/recurrent) disease;
2. Non-squamous histology (mixed adenocarcinoma histology is allowed);
3. Never smoking or light smoking history (≤10 pack years);
4. Measureable disease by RECIST 1.1;
5. 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;
6. Age ≥ 18 years;
7. Ability to provide written informed consent;
8. Agreement to provide blood sample prior to starting systemic treatment;
9. Eligibility for targeted therapy in the opinion of the investigator;
10. Standard-of-care tissue genotyping ordered or planned. Patients with tissue deemed insufficient for genotyping are eligible.
11. 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.

Exclusion Criteria:

1. Pregnancy;
2. ≥10 pack year smoking history;
3. 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;
4. Prior resection of metastatic disease if the resected metastasis was the only site of measurable disease;
5. Radiation of a metastatic lesion or residual disease if administered to the only site(s) of advanced disease;
6. 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.