Condition: Non-small Cell Lung Cancer · Sponsor: Merck Sharp & Dohme LLC
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).
This description comes directly from the study's public registry record.
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| CBCC Global Research, Inc. ( Site 0123) | Bakersfield, California, United States | Recruiting |
| Beverly Hills Cancer Center ( Site 0116) | Beverly Hills, California, United States | Recruiting |
| Stamford Hospital ( Site 0136) | Stamford, Connecticut, United States | Recruiting |
| Mount Sinai Cancer Center ( Site 0137) | Miami Beach, Florida, United States | Completed |
| Orchard Healthcare Research Inc. ( Site 0115) | Skokie, Illinois, United States | Recruiting |
| Truman Medical Center ( Site 0126) | Kansas City, Missouri, United States | Recruiting |
| Cox Medical Center North ( Site 0133) | Springfield, Missouri, United States | Recruiting |
| St. Vincent Frontier Cancer Center-Research ( Site 0105) | Billings, Montana, United States | Recruiting |
| Atlantic Health System Morristown Medical Center ( Site 0121) | Morristown, New Jersey, United States | Recruiting |
| New York Oncology Hematology, P.C. ( Site 0132) | Albany, New York, United States | Recruiting |
| University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103) | Cincinnati, Ohio, United States | Recruiting |
| Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106) | Kettering, Ohio, United States | Completed |
+ 213 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06345729