MK-1084-004
A Study of Calderasib Plus Pembrolizumab in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer With Programmed Cell Death Ligand 1 Tumor Proportion Score ≥50%
Recruiting
Trial purpose
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).
View full trial information on Clinicaltrials.govNATIONAL TRIAL REFERENCE NUMBER
NCT06345729
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Eligibility
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Conditions
Non-small Cell Lung Cancer
Age Range
18+
Sex
Male/Female
About the trial
Current trial Phase
Phase 3
Tests the medicine or vaccine in approximately 1,000 to 5,000 participants. For medicines, participants have the disease or condition the medicine is designed to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Trial start date 05-24-2024
- Estimated primary completion date 02-19-2029
- Estimated trial completion date 02-18-2031
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.