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)

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 Vers

Trial Details

NCT ID
NCT06345729
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Calderasib
  • Placebo
  • Pembrolizumab
Locations (sample)
  • Bakersfield, California, United States|35.37329,-119.01871
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Stamford, Connecticut, United States|41.05343,-73.53873
  • Miami Beach, Florida, United States|25.79065,-80.13005
  • Skokie, Illinois, United States|42.03336,-87.73339

Key Eligibility Criteria

  • Inclusion Criteria:
  • Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplin…
  • Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irrad…

For full eligibility, visit ClinicalTrials.gov.

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