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
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282) Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| Hospital São Lucas da PUCRS ( Site 0283) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286) Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Recruiting |
| Hospital Paulistano ( Site 0280) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Bradfordhill ( Site 0160) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Fundación Arturo López Pérez ( Site 0161) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Guangdong Provincial People s Hospital ( Site 0300) Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Yunnan Province Cancer Hospital ( Site 0302) Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Recruiting |
| Queen Mary Hospital ( Site 0230) Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Hong Kong United Oncology Centre ( Site 0232) Coordinator of this site? Confirm its status | Jordan | Hong Kong SAR China | Recruiting |
| Prince of Wales Hospital ( Site 0231) Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Recruiting |
| Orszagos Koranyi Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Not yet recruiting |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Not yet recruiting |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet Coordinator of this site? Confirm its status | Szolnok | Hungary | Not yet recruiting |
| Shaare Zedek Medical Center ( Site 0186) Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Meir Medical Center ( Site 0181) Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| Sheba Medical Center ( Site 0180) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Istituto San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Severance Hospital, Yonsei University Health System ( Site 0080) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Not yet recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| University of Illinois Hospital & Health Sciences System ( Site 0044) Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Clermont Oncology Center ( Site 0041) Coordinator of this site? Confirm its status | Clermont | United States | Recruiting |
| Providence Oncology and Hematology Care Clinic - Westside ( Site 0059) Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Providence Portland Medical Center ( Site 0043) Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.