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.
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)
Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has a gastrointestinal disorder affecting absorption
Parallel
Calderasib
DrugAdministered as an oral tablet
Pembrolizumab (+) Berahyaluronidase alfa
Biological/VaccineAdministered as a SC injection
Pemetrexed
DrugAdministered as an IV Infusion
Cisplatin
DrugAdministered as an IV Infusion
Carboplatin
DrugAdministered as an IV Infusion
Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.
PFS in All Participants
PFS is defined as the time from randomization until either documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS as determined by BICR will be presented.
Overall Survival (OS) in Participants with PD-L1 TPS ≥1%
OS is defined as the time from randomization to death due to any cause.
OS in Participants in All Participants
OS is defined as the time from randomization to death due to any cause.
Overall Response Rate (ORR) in All Participants
ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
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