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)
Official title: A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)
Is NCT06345729 recruiting? Yes, currently enrolling (Oct 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 is one primary study hypothesis: 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
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) expression (TPS ≥50%)
programmed cell death ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
Disease stage
Required: Stage IIIB, IIIC, IV
Prior therapy
Cannot have received: systemic anticancer therapy for locally advanced or metastatic nsclc
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 →Frequently asked questions
Is NCT06345729 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy for locally advanced or metastatic nsclc disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS g12c is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify