Clinical trial • Phase III • Oncology

MK-1084 for Non-small cell lung cancer (KRAS G12C-mutant)

Phase III trial of MK-1084 for Non-small cell lung cancer (KRAS G12C-mutant).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (KRAS G12C-mutant)
Trial Stage
Phase III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
09-01-2026
First CTIS Authorization Date
20-04-2026

Trial design

Randomised, adjuvant placebo for mk-1084 plus mk-3475a (pembrolizumab, subcutaneous) versus adjuvant mk-1084 (oral film-coated tablet) plus mk-3475a (pembrolizumab, subcutaneous). dosing and schedule not specified in the provided record.-controlled Phase III trial across 45 sites in France, Germany, Greece and others.

Randomised
Yes
Comparator
Adjuvant Placebo for MK-1084 plus MK-3475A (pembrolizumab, subcutaneous) versus adjuvant MK-1084 (oral film-coated tablet) plus MK-3475A (pembrolizumab, subcutaneous). Dosing and schedule not specified in the provided record.
Target Sample Size
256

Eligibility

Recruits 256 No vulnerable populations selected; informed consent obtained from adult participants only. Country-specific adult consent forms are included in the submitted documents (e.g., France, Germany, Greece, Italy, Spain, Poland). No paediatric assent or paediatric consent procedures are indicated..

Vulnerable Population
No vulnerable populations selected; informed consent obtained from adult participants only. Country-specific adult consent forms are included in the submitted documents (e.g., France, Germany, Greece, Italy, Spain, Poland). No paediatric assent or paediatric consent procedures are indicated.

Inclusion criteria

  • {"criterion_text":"-Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria: •\tHas newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC •\tHas completely resected, pathological Stage IIA–IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy"}
  • {"criterion_text":"-Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation"}
  • {"criterion_text":"-No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention."}
  • {"criterion_text":"-Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization"}
  • {"criterion_text":"-Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention"}
  • {"criterion_text":"-Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy"}
  • {"criterion_text":"-Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load"}
  • {"criterion_text":"-Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable"}

Exclusion criteria

  • {"criterion_text":"-Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus"}
  • {"criterion_text":"-HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease"}
  • {"criterion_text":"-Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)"}
  • {"criterion_text":"-Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention"}
  • {"criterion_text":"-Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)"}
  • {"criterion_text":"-Has known additional malignancy that is progressing or has required active treatment within the past 3 years"}
  • {"criterion_text":"-Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy"}
  • {"criterion_text":"-Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease"}
  • {"criterion_text":"-Has active infection requiring systemic therapy"}
  • {"criterion_text":"-Has not adequately recovered from major surgery or has ongoing surgical complications"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Disease-Free Survival (DFS)","definition_or_measurement_approach":"As assessed by investigator"}

Secondary endpoints

  • {"endpoint_text":"-Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Distant Metastasis-Free Survival (DMFS)","definition_or_measurement_approach":"As assessed by investigator"}
  • {"endpoint_text":"-Lung Cancer Specific Survival (LCSS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 (combined score of items 29 and 30)"}
  • {"endpoint_text":"-Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 (combined score of items 1–5)"}
  • {"endpoint_text":"-Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 (combined score of items 6 and 7)"}
  • {"endpoint_text":"-Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 (item 8)"}
  • {"endpoint_text":"-Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score","definition_or_measurement_approach":"Measured using the EORTC QLQ-LC24 (combined score of items 31 and 52)"}
  • {"endpoint_text":"-Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score","definition_or_measurement_approach":"Measured using the EORTC QLQ-LC24 (item 40)"}
  • {"endpoint_text":"-Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing any adverse event"}
  • {"endpoint_text":"-Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to adverse events"}

Recruitment

Planned Sample Size
256
Recruitment Window Months
172
Consent Approach
Informed consent obtained from adult participants; country-specific main adult consent forms are submitted (documents for France, Germany, Greece, Italy, Spain, Poland). Optional consent addenda (e.g., pregnancy follow-up, pregnant partner) are included for some countries. No paediatric assent/consent procedures are indicated.

Geography

Total Number Of Sites
45
Total Number Of Participants
102

France

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
38
Number Of Sites
11
Number Of Participants
18

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Pneumology
Contact Person Name
Claire Bardel
Contact Person Email
Claire.bardel@chu-bordeaux.fr
Site Name
HIA Sainte Anne
Department Name
Respiratory
Contact Person Name
Olivier Bylicki
Site Name
Centre Francois Baclesse
Department Name
Pneumology
Contact Person Name
Hubert Curcio
Contact Person Email
h.curcio@baclesse.unicancer.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Pulmonology, Allergy and Thoracic Oncology
Contact Person Name
Adrien Dixmier
Contact Person Email
adrien.dixmier@chu-orleans.fr
Site Name
Clinique De L'Europe
Department Name
Pneumology
Contact Person Name
Charles Dayen
Contact Person Email
c.dayen@ch-stquentin.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncology Medical
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
CHRU De Nancy
Department Name
Pneumology
Contact Person Name
Gautier Treffel
Contact Person Email
G.TREFFEL@chru-nancy.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Thoracic oncology
Contact Person Name
Laurent Greillier
Contact Person Email
laurent.greillier@ap-hm.fr
Site Name
Hopital Ambroise Pare
Department Name
Respiratory Diseases and Thoracic Oncology
Contact Person Name
Etienne Giroux Leprieur
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Pulmonology
Contact Person Name
Jean-Baptiste Assie
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Centre de Cancérologie du Grand Montpellier
Contact Person Name
Catherine Becht
Contact Person Email
becht@ccgm.fr

Germany

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
9
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik
Contact Person Name
Benjamin Schmidt
Contact Person Email
ben.schmidt@uke.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxonkologie
Contact Person Name
Helge Bischoff
Site Name
Katholisches Marienkrankenhaus gGmbH
Department Name
- ZIM - Onkologisches Studienzentrum
Contact Person Name
Gunnar Hapke
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik III - Pulmologie
Contact Person Name
Sabine Bohnet
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik IV Organonkologie
Contact Person Name
Thomas Wehler
Contact Person Email
organonkologie@uk-gm.de

Greece

Earliest CTIS Part Ii Submission Date
28-01-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
82
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Clinic of Aristotle University of Thessaloniki (AUTh)
Contact Person Name
Dionisios (Gerasimos) Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
Henry Dunant Hospital Center
Department Name
D Oncology Clinical Trial Unit
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Clinic
Contact Person Name
Vasileios Ramfidis
Contact Person Email
ramfidis@gmail.com
Site Name
Metaxa Cancer Center Hospital Of Piraeus
Department Name
Pathology - Oncοlogy Clinic
Contact Person Name
Evangelos Georgios Fergadis
Contact Person Email
fergadis@metaxa-hospital.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3rd University Department of Internal Medicine
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Evangelismos S.A.
Department Name
Oncology Clinic, Ahepa Building
Contact Person Name
Theodoros Tegos
Contact Person Email
h_tegos@yahoo.com
Site Name
Metaxa Cancer Center Hospital Of Piraeus (additional listing)
Department Name
Pathology - Oncοlogy Clinic
Contact Person Name
Evangelos Georgios Fergadis
Contact Person Email
fergadis@metaxa-hospital.gr

Italy

Earliest CTIS Part Ii Submission Date
10-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
48
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Ospedale S G Moscati
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Salvatore Pisconti
Site Name
Istituto Nazionale Dei Tumori
Department Name
Thoracic Cancer Unit – Department of Medical Oncology 1
Contact Person Name
Marta Brambilla
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologi Toracica
Contact Person Name
Ilaria Attili
Contact Person Email
ilaria.attili@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
DH Oncologia Medica, Ala E piano VIII
Contact Person Name
Emilio Bria
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O Oncologia Medica ed Ematologia
Contact Person Name
Luca Toschi

Spain

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
23
Number Of Sites
10
Number Of Participants
30

Sites

Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Medical Oncology
Contact Person Name
Belén Rubio Viqueira
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Medical Oncology
Contact Person Name
Teresa Garcia Manrique
Contact Person Email
tgarciamanrique.onco@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
Carlos Aguado de la Rosa
Site Name
Hospital Universitario Regional De Malaga
Department Name
Medical Oncology
Contact Person Name
Alexandra Cantero González
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Alejandro Martinez Martí
Contact Person Email
amarinezmarti@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Joaquim Bosch Barrera
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Contact Person Name
Javier De Castro Carpeño
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Medical Oncology
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Universitario Quironsalud Madrid (additional listing)
Department Name
Medical Oncology
Contact Person Name
Belén Rubio Viqueira

Poland

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
12
Number Of Sites
7
Number Of Participants
8

Sites

Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
III Klinika Chorób Płuc i Onkologii
Contact Person Name
Mateusz Polaczek
Contact Person Email
bk3@igichp.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Jacek Kabut
Contact Person Email
sekretariat@uck.katowice.pl
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Kamil Kuc
Contact Person Email
kkuc@wszp.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z Pododdziałem Chemioterapii
Contact Person Name
Jaroslaw Kolb-Sielecki
Contact Person Email
sekretariat@wmccp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Pluca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
paulina.kukwa@nio.gov.pl
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Kliniczny Chirurgii Klatki Piersiowej i Chirurgii Onkologicznej
Contact Person Name
Piotr Kocon
Contact Person Email
kaniutek98@gmail.com
Site Name
National Institute Of Tuberculosis And Lung Diseases (additional listing)
Department Name
III Klinika Chorób Płuc i Onkologii
Contact Person Name
Mateusz Polaczek
Contact Person Email
bk3@igichp.edu.pl

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties code: 3
Name
Icon (Lr) Limited
Responsibilities
sponsorDuties code: 4
Name
Bioclinica Inc.
Responsibilities
Central Imaging
Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties code: 7
Name
Fortrea Inc.
Responsibilities
sponsorDuties code: 1
Name
Hematogenix Laboratory Services LLC
Responsibilities
sponsorDuties code: 4
Name
Syneos Health Clinique Inc.
Responsibilities
sponsorDuties code: 4

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
MK-1084
Active Substance
MK-1084
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised
Investigational Product Name
MK-3475A
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
Authorised
Maximum Dose
7110 mg (max total amount field present in record)
Investigational Product Name
Placebo for MK-1084
Modality
Other
Authorisation Status
Not authorised/Placebo
Investigational Product Name
CARBOPLATIN
Active Substance
Carboplatin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Not authorised/auxiliary (prodAuthStatus 2)
Investigational Product Name
PEMETREXED DISODIUM
Active Substance
Pemetrexed disodium
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Not authorised/auxiliary (prodAuthStatus 2)
Investigational Product Name
CISPLATIN
Active Substance
Cisplatin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Not authorised/auxiliary (prodAuthStatus 2)
Combination Treatment
Yes

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