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 — DRUG
    Per 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

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Chicago Medical CenterChicagoIllinois60637
Christine Bestvina
The Sidney Kimmel Comprehensive Cancer CentreBaltimoreMaryland21231
Valsamo Anagnostou
410-502-3696

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