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RECRUITING
NCT07286149
PHASE1/PHASE2

A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2026-04-30

Completion Date

2037-05-06

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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.

Locations (4)

Clermont Oncology Center ( Site 0041)

Clermont, Florida, United States

Shaare Zedek Medical Center ( Site 0186)

Jerusalem, Israel

Sheba Medical Center ( Site 0180)

Ramat Gan, Israel

Severance Hospital, Yonsei University Health System ( Site 0080)

Seoul, South Korea