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RECRUITING
NCT07252739
PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers want to learn if using a study medicine called MK-1084 can help treat 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-12-19

Completion Date

2033-01-14

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

MK-1084

Oral Administration

BIOLOGICAL

Pembrolizumab

Intravenous administration

BIOLOGICAL

Cetuximab

Intravenous administration

DRUG

Carboplatin

Intravenous administration

DRUG

Pemetrexed

Intravenous administration

Locations (15)

Clermont Oncology Center ( Site 0041)

Clermont, Florida, United States

HYKS Syöpätautien klinikka ( Site 0260)

Helsinki, Uusimaa, Finland

Deventer Ziekenhuis ( Site 0272)

Deventer, Overijssel, Netherlands

Leids Universitair Medisch Centrum ( Site 0273)

Leiden, South Holland, Netherlands

Severance Hospital Yonsei University Health System ( Site 0080)

Seoul, South Korea

Hacettepe Universite Hastaneleri ( Site 0140)

Ankara, Turkey (Türkiye)

COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139)

Cherkasy, Cherkasy Oblast, Ukraine

Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 0465)

Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine

Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0132)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 0467)

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 0133)

Lviv, Lviv Oblast, Ukraine

Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 0131)

Vinnitsya, Vinnytsia Oblast, Ukraine

Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 0137)

Uzhhorod, Zakarpattia Oblast, Ukraine

VISION PARTNER Medical Centre ( Site 0135)

Kyiv, Ukraine

LIMITED LIABILITY COMPANY "MEDICAL CENTER "DOBROBUT-CLINIC" ( Site 0138)

Kyiv, Ukraine