Calderasib: Oral tablets
Placebo: Oral tablets
Pembrolizumab: IV infusion
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).
| Facility | City | Region | Status |
|---|---|---|---|
| CBCC Global Research, Inc. ( Site 0123) | Bakersfield | California | Recruiting |
| Beverly Hills Cancer Center ( Site 0116) | Beverly Hills | California | Recruiting |
| Stamford Hospital ( Site 0136) | Stamford | Connecticut | Recruiting |
| Mount Sinai Cancer Center ( Site 0137) | Miami Beach | Florida | Completed |
| Orchard Healthcare Research Inc. ( Site 0115) | Skokie | Illinois | Recruiting |
| Truman Medical Center ( Site 0126) | Kansas City | Missouri | Recruiting |
| Cox Medical Center North ( Site 0133) | Springfield | Missouri | Recruiting |
| St. Vincent Frontier Cancer Center-Research ( Site 0105) | Billings | Montana | Recruiting |
| Atlantic Health System Morristown Medical Center ( Site 0121) | Morristown | New Jersey | Recruiting |
| New York Oncology Hematology, P.C. ( Site 0132) | Albany | New York | Recruiting |
| University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103) | Cincinnati | Ohio | Recruiting |
| Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106) | Kettering | Ohio | Completed |
| Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134) | Lancaster | Pennsylvania | Recruiting |
| Oncology Consultants P.A. ( Site 0113) | Houston | Texas | Recruiting |
| Circuit Clinical/SSM Health Dean Medical Group ( Site 0129) | Madison | Wisconsin | Recruiting |
| AUSTRAL MEDICAL CENTER ( Site 0302) | CABA | Buenos Aires | Completed |
| Centro Oncologico Korben ( Site 0304) | CABA | Buenos Aires | Recruiting |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300) | Mar del Plata | Buenos Aires | Recruiting |
| Fundacion Estudios Clinicos ( Site 0306) | Rosario | Santa Fe Province | Recruiting |
| Sanatorio Parque ( Site 0301) | Rosario | Santa Fe Province | Recruiting |
| Chris O'Brien Lifehouse ( Site 3000) | Camperdown | New South Wales | Recruiting |
| Cancer Care Service Hervey Bay ( Site 3003) | Urraween | Queensland | Recruiting |
| Frankston Hospital ( Site 3002) | Frankston | Victoria | Recruiting |
| One Clinical Research ( Site 3001) | Nedlands | Western Australia | Recruiting |
| Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401) | Graz | Styria | Recruiting |
| Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400) | Vienna | Austria | Recruiting |
| Hospital Mario Penna ( Site 0436) | Belo Horizonte | Minas Gerais | Recruiting |
| Hospital de Câncer de Recife ( Site 0447) | Recife | Pernambuco | Recruiting |
| Oncoclínica Oncologistas Associados ( Site 0441) | Teresina | Piauí | Recruiting |
| Liga Norte Riograndense Contra o Câncer ( Site 0439) | Natal | Rio Grande do Norte | Recruiting |
| Hospital de Caridade de Ijuí ( Site 0438) | Ijuí | Rio Grande do Sul | Recruiting |
| Hospital de Clínicas de Passo Fundo ( Site 0442) | Passo Fundo | Rio Grande do Sul | Recruiting |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435) | Porto Alegre | Rio Grande do Sul | Recruiting |
| Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437) | Barretos | São Paulo | Recruiting |
| Instituto Nacional de Câncer - INCA ( Site 0446) | Rio de Janeiro | Brazil | Recruiting |
| Americas ( Site 0431) | Rio de Janeiro | Brazil | Recruiting |
| MBAL Uni Hospital-Department of Medical Oncology ( Site 1000) | Panagyurishte | Pazardzhik | Recruiting |
| Multiprofile Hospital for Active Treatment SerdikaМЕD EOOD-Second Department of Medical Oncology ( Site 1002) | Sofia | Sofia (stolitsa) | Recruiting |
| MHAT - Heart and Brain ( Site 1006) | Pleven | Bulgaria | Recruiting |
| Medical Center Futuremeds ( Site 1007) | Plovdiv | Bulgaria | Recruiting |
+ 185 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06345729 on ClinicalTrials.gov ↗ ← All trials in the UK