Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Canadian Cancer Trials Group
- Study ID
- NCT04093167
- Phase
- PHASE2/PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pembrolizumab — DRUGPer current Product Monograph/U.S. Drug Label and/or local guidelines.
Study Details
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.
Key Dates
- Start date
- May 26, 2020
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2026
- Completion
- Jul 30, 2027
Study Design
- Enrollment
- 230 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Pembrolizumab alone
- Experimental: Pembrolizumab + standard platinum-based chemotherapy
Primary Outcome Measure
Stage 1: Concordance rate between molecular response and radiologic response [ Time Frame: 18 months ]
Central Contacts
- Janet Dancey613-533-6430
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | Christine Bestvina |
| The Sidney Kimmel Comprehensive Cancer Centre | Baltimore | Maryland | 21231 | Valsamo Anagnostou 410-502-3696 |
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