A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Time frame: Up to 42 days
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 65 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 64 months
Objective Response Rate (ORR)
Time frame: Up to approximately 65 months
Secondary Endpoints
Duration of Response (DOR)
Progression-Free Survival (PFS)
Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC tau)
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) * Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations * Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy * Provides archival tumor tissue sample of a tumor lesion not previously irradiated * Has provided tissue prior to treatment allocation/randomization from a newly obtained biopsy of a tumor lesion not previously irradiated * Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol Exclusion Criter…
Read full criteria on CT.gov →✦ Analyst Commentary
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