OncoMatch/Clinical Trials/NCT04093167
Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer
Is NCT04093167 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Pembrolizumab for lung cancer.
Treatment: Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
Confirmed EGFR and ALK mutation-negative disease based on testing consistent with local guidelines.
Required: ALK wild-type
Confirmed EGFR and ALK mutation-negative disease based on testing consistent with local guidelines.
Required: PD-L1 (CD274) TPS ≥ 50% (Tumour Proportion Score (TPS) ≥ 50%)
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 consistent with local guidelines and regulatory approvals may be eligible following discussion with CCTG.
Disease stage
Required: Stage IV, III
Metastatic disease required
Histologically or cytologically confirmed metastatic NSCLC. Patients with stage III disease are eligible if they are not candidates for surgical resection or definitive chemoradiation.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: concurrent anti-cancer therapy or investigational anti-cancer agents
Concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents
Lab requirements
Blood counts
White Blood Cells ≥ 2.0 x 10^9/L (2000/μL); Absolute neutrophils ≥ 1.5 x 10^9/L (1500/μL); Platelets ≥ 100 x 10^9/L (100 x 10^3/μL)
Kidney function
Serum creatinine or Creatinine clearance ≤ 1.5 x ULN OR ≥ 40 mL/min
Liver function
Bilirubin ≤ 1.5 x ULN; AST and/or ALT ≤ 3 x ULN, < 5 x ULN for patients with liver metastases
Adequate hematology and organ function to continue immunotherapy or receive standard platinum combination therapy (must be done prior to registration for ctDNA testing) and prior to enrollment and randomization).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Chicago Medical Center · Chicago, Illinois
- The Sidney Kimmel Comprehensive Cancer Centre · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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