A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
Merck Sharp & Dohme LLC
Summary
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c * If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Has active inflammatory bowel disease requiring immunosuppressiv…
Interventions
- DrugCalderasib
Administered as an oral tablet
- BiologicalPembrolizumab (+) Berahyaluronidase alfa
Administered as a SC injection
- DrugPemetrexed
Administered as an IV Infusion
- DrugCisplatin
Administered as an IV Infusion
- DrugCarboplatin
Administered as an IV Infusion
Locations (149)
- Central Alabama Research ( Site 0108)Birmingham, Alabama
- Stamford Hospital ( Site 0126)Stamford, Connecticut
- Mount Sinai Cancer Center ( Site 0137)Miami Beach, Florida
- Indiana University Health Arnett Cancer Center ( Site 0116)Lafayette, Indiana
- New England Cancer Specialists ( Site 0139)Westbrook, Maine
- New York Oncology Hematology, P.C. ( Site 0119)Albany, New York