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NCT07286149RecruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
140 (estimated)
First submitted
17 Nov 2025
Start date
30 Apr 2026
Primary completion date
17 Aug 2029
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
NCT number
NCT07286149
EU CT number
2024-512248-47-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 140
  • From 30 Apr 2026 to the primary completion date, 17 Aug 2029
  • 39 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Other illness

  • Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Has evidence of any leptomeningeal disease
  • Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or current ILD, or suspected ILD
  • Has an active infection requiring systemic therapy

Other

  • The main exclusion criteria include but are not limited to the following:
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Who the study is looking for

  • The main inclusion criteria include but are not limited to the following:
  • Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
  • Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations
  • Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy
  • Has provided tumor tissue for biomarker analysis from an archival sample or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)
Coordinator of this site? Confirm its status
BarretosBrazilRecruiting
Hospital São Lucas da PUCRS ( Site 0283)
Coordinator of this site? Confirm its status
Porto AlegreBrazilRecruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286)
Coordinator of this site? Confirm its status
São José do Rio PretoBrazilRecruiting
Hospital Paulistano ( Site 0280)
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162)
Coordinator of this site? Confirm its status
SantiagoChileRecruiting
Bradfordhill ( Site 0160)
Coordinator of this site? Confirm its status
SantiagoChileRecruiting
Fundación Arturo López Pérez ( Site 0161)
Coordinator of this site? Confirm its status
SantiagoChileRecruiting
Guangdong Provincial People s Hospital ( Site 0300)
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GuangzhouChinaRecruiting
Yunnan Province Cancer Hospital ( Site 0302)
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KunmingChinaRecruiting
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
General Hospital of Athens - Alexandra
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AthensGreeceRecruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceRecruiting
Queen Mary Hospital ( Site 0230)
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Hong KongHong Kong SAR ChinaRecruiting
Hong Kong United Oncology Centre ( Site 0232)
Coordinator of this site? Confirm its status
JordanHong Kong SAR ChinaRecruiting
Prince of Wales Hospital ( Site 0231)
Coordinator of this site? Confirm its status
ShatinHong Kong SAR ChinaRecruiting
Orszagos Koranyi Pulmonologiai Intezet
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Budapest XIIHungaryNot yet recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz
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KecskemétHungaryNot yet recruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
Coordinator of this site? Confirm its status
SzolnokHungaryNot yet recruiting
Shaare Zedek Medical Center ( Site 0186)
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Meir Medical Center ( Site 0181)
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Kfar SabaIsraelRecruiting
Sheba Medical Center ( Site 0180)
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Ramat GanIsraelRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyRecruiting
Istituto San Raffaele
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MilanItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Severance Hospital, Yonsei University Health System ( Site 0080)
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandNot yet recruiting
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
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KoszalinPolandNot yet recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
University of Illinois Hospital & Health Sciences System ( Site 0044)
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ChicagoUnited StatesRecruiting
Clermont Oncology Center ( Site 0041)
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ClermontUnited StatesRecruiting
Providence Oncology and Hematology Care Clinic - Westside ( Site 0059)
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Providence Portland Medical Center ( Site 0043)
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.