RecruitingPhase 1Phase 2NCT07286149

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

Sponsor

Merck Sharp & Dohme LLC

Enrollment

190 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Lung Neoplasm Malignant

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called MK-1084 combined with other treatments for people with advanced non-small cell lung cancer (NSCLC) that has a specific gene mutation called KRAS G12C and has already been treated with standard immunotherapy and chemotherapy. **You may be eligible if...** - You have advanced or metastatic non-squamous NSCLC - Your tumor or blood test has confirmed a KRAS G12C mutation - Your cancer has progressed after 1–2 prior lines of treatment including a PD-1/PD-L1 immunotherapy and platinum-based chemotherapy - You have accessible tumor tissue for biopsy - Your performance level and organ function are adequate **You may NOT be eligible if...** - Your lung cancer does not have the KRAS G12C mutation - You have not yet received the required prior treatments - You have had more than 2 prior lines of treatment - You have untreated brain metastases or other serious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMK-1084

Oral administration

BIOLOGICALPatritumab deruxtecan

IV infusion

BIOLOGICALSacituzumab tirumotecan

IV Infusion

BIOLOGICALCetuximab

IV Infusion

DRUGRescue 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.