Tests calderasib with pembrolizumab as first treatment for KRAS G12C lung cancer
Tests calderasib and pembrolizumab together in adults with KRAS G12C-mutant advanced lung cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Key facts
- Where
- Bergamo, Bolzano, Catanzaro, Florence, Meldola, Milan, Modena, Naples, Pavia, Rome, Rozzano, Statte, Udine, and Verona, ItalySee the 15 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT07190248, who can take part
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Sanitaria Dell'Alto AdigeBolzano, ItalyTaking people
- Azienda Ospedaliero Universitaria Renato DulbeccoCatanzaro, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda Ospedaliera S Giovanni AddolorataRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Ospedale S.G. MoscatiStatte, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07190248EU 2024-514500-14-00
- Record updated
- 10 November 2026
- Original description
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.Read full original descriptionShow less
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)
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.
The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Inclusion: The main inclusion criteria include but are not limited to the following:; Has nonsquamous 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).
Exclusion: 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; Has not adequately recovered from major surgery or has ongoing surgical complications; Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements; 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; 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; The main exclusion criteria include but are not limited to the following:; Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.