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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

2026-05-26

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 (18)

Clermont Oncology Center ( Site 0041)

Clermont, Florida, United States

University of Illinois Hospital & Health Sciences System ( Site 0044)

Chicago, Illinois, United States

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)

Barretos, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286)

São José do Rio Preto, São Paulo, Brazil

Hospital Paulistano ( Site 0280)

São Paulo, São Paulo, Brazil

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162)

Santiago, Region M. de Santiago, Chile

FALP ( Site 0161)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0160)

Santiago, Region M. de Santiago, Chile

Guangdong Provincial People s Hospital ( Site 0300)

Guangzhou, Guangdong, China

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)

Athens, Attica, Greece

Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205)

Athens, Attica, Greece

Queen Mary Hospital ( Site 0230)

Hong Kong, Hong Kong

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

Institut Català d'Oncologia - L'Hospitalet ( Site 0090)

Hospitalet, Barcelona, Spain

Hospital Clinic de Barcelona ( Site 0092)

Barcelona, Spain

Hospital Universitario Virgen Macarena ( Site 0093)

Seville, Spain