OncoMatch/Clinical Trials/NCT06345729
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Is NCT06345729 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Pembrolizumab and Calderasib for non-small cell lung cancer.
Treatment: Calderasib · Pembrolizumab — This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses: Hypothesis 1: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Hypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KRAS G12C
central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status
Required: PD-L1 (CD274) tumor proportion score (TPS) ≥50% (TPS ≥50%)
Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
Disease stage
Required: Stage IIIB, IIIC, IV (M1A, M1B, OR M1C) (AJCC Staging Manual, Version 8)
Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation... or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
Prior therapy
Cannot have received: systemic anticancer therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- CBCC Global Research, Inc. ( Site 0123) · Bakersfield, California
- Beverly Hills Cancer Center ( Site 0116) · Beverly Hills, California
- Stamford Hospital ( Site 0136) · Stamford, Connecticut
- Mount Sinai Cancer Center ( Site 0137) · Miami Beach, Florida
- Orchard Healthcare Research Inc. ( Site 0115) · Skokie, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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