NCT07286149

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn: * About the safety of MK-1084 and if people tolerate it when taken with other treatments * How many people have the cancer respond (get smaller or go away) to the treatments

Detailed description

This is a substudy of the master protocol MK-3475-U01 (KEYMAKER-U01) - NCT04165798.

Conditions

• Lung Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	MK-1084	Oral administration
BIOLOGICAL	Patritumab deruxtecan	IV infusion
BIOLOGICAL	Sacituzumab tirumotecan	IV Infusion
BIOLOGICAL	Cetuximab	IV Infusion
DRUG	Rescue Medications	Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent) for prevention of chemotherapy induced nausea and vomiting.

Timeline

• Start date: 2026-04-30
• Primary completion: 2031-08-11
• Completion: 2037-05-06
• First posted: 2025-12-16
• Last updated: 2026-04-09

Locations

4 sites across 3 countries: United States, Israel, South Korea

Regulatory

• FDA-regulated drug study