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)

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

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).

Criteri di esclusione: 

The main exclusion criteria include but are not limited to the following:

- Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- 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 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 received prior systemic anticancer therapy for their advanced or metastatic NSCLC
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- 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
- Has not adequately recovered from major surgery or has ongoing surgical complications. 

Trattamento sperimentale: 

Calderasib + Pembrolizumab (+) Berahyaluronidase alfa

Trattamento di controllo: 

Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-514500-14-00

Data di inserimento: 16.03.2026

Data di aggiornamento: 15.06.2026

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: na