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NCT07286149From ClinicalTrials.govRecruiting

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

  • Lung Neoplasm Malignant

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
140
Started
30 April 2026
Main results due
17 August 2029
Study sites
29
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* 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 known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has evidence of any leptomeningeal disease
* Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization
* 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 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 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
* Has not adequately recovered from major surgery or has ongoing surgical complications

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(29)

  • Clermont Oncology Center ( Site 0041)

    Clermont, Florida, United States

    Recruiting

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

    Chicago, Illinois, United States

    Recruiting

  • Providence Portland Medical Center ( Site 0043)

    Portland, Oregon, United States

    Recruiting

  • Providence Oncology and Hematology Care Clinic - Westside ( Site 0059)

    Portland, Oregon, United States

    Recruiting

  • Hospital São Lucas da PUCRS ( Site 0283)

    Porto Alegre, Rio Grande do Sul, Brazil

    Recruiting

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

    Barretos, São Paulo, Brazil

    Recruiting

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

    São José do Rio Preto, São Paulo, Brazil

    Recruiting

  • Hospital Paulistano ( Site 0280)

    São Paulo, São Paulo, Brazil

    Recruiting

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • FALP ( Site 0161)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • Bradfordhill ( Site 0160)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • Guangdong Provincial People s Hospital ( Site 0300)

    Guangzhou, Guangdong, China

    Recruiting

  • Yunnan Province Cancer Hospital ( Site 0302)

    Kunming, Yunnan, China

    Recruiting

  • UniversitaetsklInikum Tuebingen ( Site 0192)

    Tübingen, Baden-Wurttemberg, Germany

    Recruiting

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

    Athens, Attica, Greece

    Recruiting

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

    Athens, Attica, Greece

    Recruiting

  • Papageorgiou General Hospital of Thessaloniki ( Site 0206)

    N.Efkarpia, Thessaloniki, Greece

    Recruiting

  • Queen Mary Hospital ( Site 0230)

    Hong Kong, Hong Kong

    Recruiting

  • Hong Kong United Oncology Centre ( Site 0232)

    Jordan, Hong Kong

    Recruiting

  • Prince of Wales Hospital ( Site 0231)

    Shatin, Hong Kong

    Recruiting

  • Shaare Zedek Medical Center ( Site 0186)

    Jerusalem, Israel

    Recruiting

  • Meir Medical Center ( Site 0181)

    Kfar Saba, Israel

    Recruiting

  • Sheba Medical Center ( Site 0180)

    Ramat Gan, Israel

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0176)

    Meldola, Forli-Cesena, Italy

    Recruiting

  • Severance Hospital, Yonsei University Health System ( Site 0080)

    Seoul, South Korea

    Recruiting

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

    Hospitalet, Barcelona, Spain

    Recruiting

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0091)

    Pozuelo de Alarcón, Madrid, Spain

    Recruiting

  • Hospital Clinic de Barcelona ( Site 0092)

    Barcelona, Spain

    Recruiting

  • Hospital Universitario Virgen Macarena ( Site 0093)

    Seville, Spain

    Recruiting

Showing 29 of 29 sites. 29 of the 29 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07286149. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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