KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Condition studied

Participants with KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percentage of Participants with a Dose Limiting Toxicity (DLT), Percentage of Participants who Experience at Least One Adverse Event (AE), Percentage of Participants who Discontinue Study Intervention Due to an AE, Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR)

Endpoint detail

Duration of Response (DOR) per RECIST 1.1 as assessed by BICR, Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR, Overall Survival (OS), Area Under the Concentration-Time Curve (AUC) for MK-1084, Maximum Concentration (Cmax) of MK-1084, Trough Concentration (Ctrough) of MK-1084