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
Sites (67)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Landeskrankenanstalten-Betriebsgesellschaft Kabeg Coordinator of this site? Confirm its status | Klagenfurt Am Woerthersee | Austria | Recruiting |
| Stadt Wien Wiener Gesundheitsverbund Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Algemeen Ziekenhuis klina Coordinator of this site? Confirm its status | Brasschaat | Belgium | Recruiting |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| Chu Helora Coordinator of this site? Confirm its status | La Louvière | Belgium | Recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| Klinikum Der Landeshauptstadt Stuttgart gKAöR Coordinator of this site? Confirm its status | Stuttgart | Germany | Not yet recruiting |
| Helios Universitaetsklinikum Wuppertal Coordinator of this site? Confirm its status | Wuppertal | Germany | Not yet recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Clinique de l'Europe Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Centre Hospitalier Métropole Savoie Coordinator of this site? Confirm its status | Chambéry | France | Recruiting |
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Groupe hospitalier Paris saint Joseph Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier de Pau Coordinator of this site? Confirm its status | Pau | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois Coordinator of this site? Confirm its status | VANDOEUVRE-LESNANCY | France | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. Coordinator of this site? Confirm its status | Cholargos | Greece | Recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Recruiting |
| General Hospital Of Patras Agios Andreas Coordinator of this site? Confirm its status | Patras | Greece | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| Orszagos Koranyi Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Recruiting |
| Nograd Varmegyei Szent Lazar Korhaz Coordinator of this site? Confirm its status | Salgótarján | Hungary | Recruiting |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Sanitaria Dell'Alto Adige Coordinator of this site? Confirm its status | Bolzano | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Renato Dulbecco Coordinator of this site? Confirm its status | Catanzaro | Italy | 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 |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliera S Giovanni Addolorata Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Ospedale S.G. Moscati Coordinator of this site? Confirm its status | Statte | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Stichting Elisabeth-TweeSteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Recruiting |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu Coordinator of this site? Confirm its status | Przemyśl | Poland | Recruiting |
| Onco Card S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Mnt Healthcare Europe S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colțea Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Delta Health Care S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Radiotherapy Center Cluj S.R.L. Coordinator of this site? Confirm its status | Floresti | Romania | Recruiting |
| Spitalul Municipal Ploiesti Coordinator of this site? Confirm its status | Ploieşti | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.