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NCT07190248RecruitingPhase 3

A clinical study of MK-1084 and other treatments for lung cancer (MK-1084-007)

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Oct 2026

Brief summary (registry, in English)

1. To compare MK-1084 plus MK-3475A and MK-3475A plus platinum-doublet chemotherapy with respect to PFS per RECIST 1.1 by BICR in participants whose tumors are PD-L1 positive at TPS≥1%

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
234 (estimated)
First submitted
6 Aug 2025
Start date
15 Dec 2025
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
EU CT number
2024-514500-14-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 234
  • 67 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has not adequately recovered from major surgery or has ongoing surgical complications
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea)
  • Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC

Other illness

  • Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy except those specified by protocol
  • Has history of stem cell/solid organ transplant
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has a gastrointestinal disorder affecting absorption
  • Is HIV positive and has 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 active autoimmune disease that has required systemic treatment in the past 2 years

Other

  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Who the study is looking for

  • Has nonsquamous non—small cell lung cancer (NSCLC) (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
  • If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (67)

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

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaRecruiting
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
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Klagenfurt Am WoertherseeAustriaRecruiting
Stadt Wien Wiener Gesundheitsverbund
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ViennaAustriaRecruiting
Algemeen Ziekenhuis klina
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BrasschaatBelgiumRecruiting
Ziekenhuis Oost-Limburg
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GenkBelgiumRecruiting
Chu Helora
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La LouvièreBelgiumRecruiting
CHC MontLégia
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LiègeBelgiumRecruiting
Vitaz
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Sint-NiklaasBelgiumRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyNot yet recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyNot yet recruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyNot yet recruiting
Helios Universitaetsklinikum Wuppertal
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WuppertalGermanyNot yet recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Virgen De Valme
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SevillaSpainRecruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Clinique de l'Europe
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AmiensFranceRecruiting
CHU Caen
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CaenFranceRecruiting
Centre Hospitalier Métropole Savoie
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ChambéryFranceRecruiting
Hopital Europeen Marseille
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MarseilleFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Groupe hospitalier Paris saint Joseph
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ParisFranceRecruiting
Centre Hospitalier de Pau
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PauFranceRecruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ​
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VANDOEUVRE-LESNANCYFranceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
Laiko General Hospital of Athens
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AthensGreeceRecruiting
Henry Dunant Hospital Center
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AthensGreeceRecruiting
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
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CholargosGreeceRecruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceRecruiting
General Hospital Of Patras Agios Andreas
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PatrasGreeceRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
Orszagos Koranyi Pulmonologiai Intezet
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Budapest XIIHungaryRecruiting
Nograd Varmegyei Szent Lazar Korhaz
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SalgótarjánHungaryRecruiting
Református Pulmonológiai Centrum
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TörökbálintHungaryRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Sanitaria Dell'Alto Adige
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BolzanoItalyRecruiting
Azienda Ospedaliero Universitaria Renato Dulbecco
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CatanzaroItalyRecruiting
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
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyRecruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Azienda Ospedaliera S Giovanni Addolorata
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Ospedale S.G. Moscati
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StatteItalyRecruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyRecruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyRecruiting
Amphia Hospital
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BredaNetherlandsRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Stichting Elisabeth-TweeSteden Ziekenhuis
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TilburgNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandRecruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandRecruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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PrzemyślPolandRecruiting
Onco Card S.R.L.
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BrasovRomaniaRecruiting
Mnt Healthcare Europe S.R.L.
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BucharestRomaniaRecruiting
Spitalul Clinic Colțea
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BucharestRomaniaRecruiting
Delta Health Care S.R.L
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BucharestRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaRecruiting
Radiotherapy Center Cluj S.R.L.
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FlorestiRomaniaRecruiting
Spitalul Municipal Ploiesti
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PloieştiRomaniaRecruiting

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