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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Malignant Neoplasm

Interventions

DRUG

MK-1084

Oral Administration

BIOLOGICAL

Pembrolizumab

Intravenous administration

BIOLOGICAL

Cetuximab

Intravenous administration

BIOLOGICAL

Sacituzumab tirumotecan (sac-TMT)

Injection powder for intravenous infusion

DRUG

Rescue medication

Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[Hl\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, and granulocyte colony-stimulating factor (G-CSF). A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2033-01-14
Completion
2033-01-14
FDA Drug
Yes

Countries

  • United States
  • Chile
  • China
  • Finland
  • Greece
  • Hong Kong
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07252739 on ClinicalTrials.gov