A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer
Canadian Cancer Trials Group
Summary
The standard or usual treatment for this disease is pembrolizumab given by needle into the veins (IV). Some cancers shed DNA (circulating tumour DNA or ctDNA) or genes (biomarkers) into the blood, and levels of these biomarkers may be able to tell researchers how people respond to treatment with pembrolizumab before they feel worse, or the cancer is worse on imaging tests. Researchers are studying how levels of these biomarkers can show how cancers are responding to treatment and whether adding chemotherapy to pembrolizumab based on detection of ctDNA can offer better results.
Description
This study is being done in two stages. Participants are being invited to participate in stage 2. The purpose of stage 1 of the study was to find out how soon ctDNA disappears from blood in patients with lung cancer treated with pembrolizumab and whether ctDNA disappearance or continued detection related to how well people did. In stage 2 the study will use the blood tests to figure out if patients on treatment with pembrolizumab with ctDNA that is still detected in the blood after 6 weeks of pembrolizumab could do better by adding standard chemotherapy treatment before the cancer is worse co…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed metastatic NSCLC. Patients with stage III disease are eligible if they are not candidates for surgical resection or definitive chemoradiation. Patients with Large Cell Neuroendocrine Carcinoma (LCNEC) are not eligible. * Confirmed EGFR and ALK mutation-negative disease based on testing consistent with local guidelines. * Patients must have a PD-L1 test result from a certified laboratory indicating PD-L1 expression Tumour Proportion Score (TPS) ≥ 50%. Patients with lower PD-L1 TPS scores treated with single agent pembrolizumab con…
Interventions
- DrugPembrolizumab
Per current Product Monograph/U.S. Drug Label and/or local guidelines.
Locations (10)
- The University of Chicago Medical CenterChicago, Illinois
- The Sidney Kimmel Comprehensive Cancer CentreBaltimore, Maryland
- BCCA - VancouverVancouver, British Columbia
- Health Sciences NorthGreater Sudbury, Ontario
- Juravinski Cancer Centre at Hamilton Health SciencesHamilton, Ontario
- Kingston Health Sciences CentreKingston, Ontario