drugset / Trial / NCT07252739

KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)

NCT07252739 ↗

Phase 2 Recruiting 140 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupSingle-blindTreatment

Summary

Researchers want to learn if using a study medicine called MK-1084 can help treat Non-Small Cell Lung Cancer (NSCLC). MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change. The goal of this study is to learn about the safety of MK-1084 and to learn how many people have the cancer get smaller or go away during the study treatment.

Timeline

Start
2025-12-19
Primary completion
2029-11-15
Completion
2032-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Calderasib Unknown — Oral
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous
Background Acetaminophen Small molecule — —
Background Dexamethasone Small molecule — —
Background Diphenhydramine Small molecule — —
Background Pembrolizumab Monoclonal antibody 400 mg Intravenous

Indications