Clinical trial • Phase I/II • Oncology
MK-1084 for Non-small cell lung cancer
Phase I/II trial of MK-1084 for Non-small cell lung cancer. adaptive. 133 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase I/II
- Drug Modality
- ADC | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 29-10-2025
- First CTIS Authorization Date
- 04-03-2026
Trial design
adaptive Phase I/II trial in Germany, Greece, Hungary and others.
- Adaptive
- True, rolling-arm umbrella design with dose-escalation elements (DLT-based escalation in phase 1b) and expansion into phase 2 cohorts; adaptive addition/removal of arms (rolling arms) and transition from dose-finding to efficacy evaluation with BICR-assessed endpoints.
- Biomarker Stratified
- True; biomarker: KRAS G12C mutation (participants selected on presence of KRAS G12C)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 133
Eligibility
Recruits 133 No vulnerable populations selected. Study documentation and consent materials indicate adult participants (adult consent forms present for each country); assent/parental consent is not applicable..
- Vulnerable Population
- No vulnerable populations selected. Study documentation and consent materials indicate adult participants (adult consent forms present for each country); assent/parental consent is not applicable.
Inclusion criteria
- {"criterion_text":"- Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Provides archival tumor tissue sample of a tumor lesion not previously irradiated"}
- {"criterion_text":"- Has provided tissue prior to treatment allocation/randomization from a newly obtained biopsy of a tumor lesion not previously irradiated"}
- {"criterion_text":"- Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol"}
Exclusion criteria
- {"criterion_text":"- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements"}
- {"criterion_text":"- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses"}
- {"criterion_text":"- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis"}
- {"criterion_text":"- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease"}
- {"criterion_text":"- Has evidence of any leptomeningeal disease"}
- {"criterion_text":"- Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
- {"criterion_text":"- Has received previous treatment with an agent targeting KRAS"}
- {"criterion_text":"- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment within the past 3 years"}
- {"criterion_text":"- Has history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD"}
- {"criterion_text":"- Has an active infection requiring systemic therapy"}
- {"criterion_text":"- Have not adequately recovered from major surgery or have ongoing surgical complications"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of Participants Who Experience a Dose Limiting Toxicity (DLT)","definition_or_measurement_approach":"Count of participants experiencing DLTs (safety assessment during dose-escalation period); DLTs used to inform dose-escalation decisions."}
- {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing AEs as recorded per study safety reporting procedures."}
- {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who permanently discontinue study treatment due to an adverse event."}
- {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":"ORR assessed per RECIST 1.1 as determined by blinded independent central review (BICR)."}
Secondary endpoints
- {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by BICR."}
- {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by BICR (Phase 2 only)."}
- {"endpoint_text":"- Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC tau)","definition_or_measurement_approach":"Pharmacokinetic measurement calculated from plasma concentration-time data over a dosing interval (PK characterization)."}
- {"endpoint_text":"- Maximum Plasma Concentration (Cmax)","definition_or_measurement_approach":"PK measurement of peak plasma concentration following dosing."}
- {"endpoint_text":"- Minimum Observed Concentration (Ctrough)","definition_or_measurement_approach":"PK measurement of trough plasma concentration prior to next dose."}
Recruitment
- Planned Sample Size
- 133
- Recruitment Window Months
- 76
- Consent Approach
- Informed consent obtained from adult participants. Country-specific informed consent forms provided (documents show main consent forms and optional/ancillary consents per country: Germany, Greece, Hungary, Italy, Spain, Poland). Documents include optional limited screening consent, pregnancy partner/follow-up consents, genetic consent and data privacy forms where applicable. No assent/parental consent materials for minors are provided.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 57
Germany
- Earliest CTIS Part Ii Submission Date
- 06-02-2026
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Thoracic Oncology
- Principal Investigator Name
- Farastuk Bozorgmehr
- Principal Investigator Email
- bozorgmehr@med.uni-heidelberg.de
- Contact Person Name
- Farastuk Bozorgmehr
- Contact Person Email
- bozorgmehr@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik VIII
- Principal Investigator Name
- Thorben Gross
- Principal Investigator Email
- Thorben.Gross@med.uni-tuebingen.de
- Contact Person Name
- Thorben Gross
- Contact Person Email
- Thorben.Gross@med.uni-tuebingen.de
Greece
- Earliest CTIS Part Ii Submission Date
- 27-11-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 102
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 3rd Dept of Internal Medicine and Laboratory, Oncology Department
- Principal Investigator Name
- Konstantinos Syrigos
- Principal Investigator Email
- ksyrigos.trials@gmail.com
- Contact Person Name
- Konstantinos Syrigos
- Contact Person Email
- ksyrigos.trials@gmail.com
- Site Name
- General Hospital Of Athens Alexandra
- Department Name
- Oncology – Hematology Department – Unit of Plasma Cell Dyscrasias, University of Athens
- Principal Investigator Name
- Michalis Liontos
- Principal Investigator Email
- mliontos@gmail.com
- Contact Person Name
- Michalis Liontos
- Contact Person Email
- mliontos@gmail.com
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Molecular Medicine Clinic
- Principal Investigator Name
- Georgios Lazaridis
- Principal Investigator Email
- georlaz@yahoo.gr
- Contact Person Name
- Georgios Lazaridis
- Contact Person Email
- georlaz@yahoo.gr
Hungary
- Earliest CTIS Part Ii Submission Date
- 29-01-2026
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 39
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Orszagos Koranyi Pulmonologiai Intezet
- Department Name
- Országos Korányi Pulmonológiai Intézet
- Principal Investigator Name
- Gyula Ostoros
- Principal Investigator Email
- drostorosgyula@gmail.com
- Contact Person Name
- Gyula Ostoros
- Contact Person Email
- drostorosgyula@gmail.com
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Onkoradiológiai Központ
- Principal Investigator Name
- Zsuzsanna Kelemen
- Principal Investigator Email
- kelemenzs@kmk.hu
- Contact Person Name
- Zsuzsanna Kelemen
- Contact Person Email
- kelemenzs@kmk.hu
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Onkológiai Központ
- Principal Investigator Name
- Zsuzsanna Orosz
- Principal Investigator Email
- zsuzsa.orosz@gmail.com
- Contact Person Name
- Zsuzsanna Orosz
- Contact Person Email
- zsuzsa.orosz@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 30-01-2026
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 33
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giuseppe LO RUSSO
- Principal Investigator Email
- giuseppe.lorusso@istitutotumori.mi.it
- Contact Person Name
- Giuseppe LO RUSSO
- Contact Person Email
- giuseppe.lorusso@istitutotumori.mi.it
- Site Name
- Istituto San Raffaele
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Roberto FERRARA
- Principal Investigator Email
- ferrara.roberto@hsr.it
- Contact Person Name
- Roberto FERRARA
- Contact Person Email
- ferrara.roberto@hsr.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Angelo DEL MONTE
- Principal Investigator Email
- angelo.delmonte@irst.emr.it
- Contact Person Name
- Angelo DEL MONTE
- Contact Person Email
- angelo.delmonte@irst.emr.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Dipartimento di Scienze Biomediche
- Principal Investigator Name
- Lorenzo LIVI
- Principal Investigator Email
- lorenzo.livi@unifi.it
- Contact Person Name
- Lorenzo LIVI
- Contact Person Email
- lorenzo.livi@unifi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 05-02-2026
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 28
- Number Of Sites
- 3
- Number Of Participants
- 22
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ernest Nadal Alforja
- Principal Investigator Email
- contactfortrialsICOLH@iconcologia.net
- Contact Person Name
- Ernest Nadal Alforja
- Contact Person Email
- contactfortrialsICOLH@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laura Mezquita Pérez
- Principal Investigator Email
- LMEZQUITA@clinic.cat
- Contact Person Name
- Laura Mezquita Pérez
- Contact Person Email
- LMEZQUITA@clinic.cat
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Medical Oncology
- Principal Investigator Name
- David Vicente Baz
- Principal Investigator Email
- david.vbaz@gmail.com
- Contact Person Name
- David Vicente Baz
- Contact Person Email
- david.vbaz@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 23-01-2026
- Latest Decision Or Authorization Date
- 07-03-2026
- Processing Time Days
- 43
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
- Principal Investigator Name
- Mariusz Kwiatkowski
- Principal Investigator Email
- sekretariat.odch@swk.med.pl
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- sekretariat.odch@swk.med.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badań Klinicznych UCK, Ośrodek Badań Klinicznych Wczesnych Faz
- Principal Investigator Name
- Magdalena Błaszkowska
- Principal Investigator Email
- obkwf@uck.gda.pl
- Contact Person Name
- Magdalena Błaszkowska
- Contact Person Email
- obkwf@uck.gda.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej
- Principal Investigator Name
- Dariusz Kowalski
- Principal Investigator Email
- paulina.kukwa@nio.gov.pl
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- paulina.kukwa@nio.gov.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
- PPD Development LP
- Name
- Bioclinica Inc.
- Responsibilities
- ILD adjudication; image collection and BICR services
- Name
- PPD Global Central Labs
- Name
- Almac Clinical Services LLC
- Name
- Frontage Laboratories Inc.
- Responsibilities
- Referral lab PK/ADA
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- Referral lab PK/ADA
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":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ILD Adjudication RE: MK-2870, MK-1022","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Image collection, quality check, BICR per RECIST 1.1 (including expedited verification of eligibility and verification of progression services), BICR per RANO-BM","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Referral Lab (MK-1084) PK/ADA","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"Referral Lab (MK-2870) PK/ADA","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MK-1084
- Active Substance
- MK-1084
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Investigational Product Name
- MK-1022
- Active Substance
- PATRITUMAB DERUXTECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised
- Investigational Product Name
- MK-2870
- Active Substance
- SACITUZUMAB TIRUMOTECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised
- Investigational Product Name
- CETUXIMAB
- Active Substance
- CETUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Not authorised
- Combination Treatment
- Yes
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