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)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07190248Tipo: INTERVENTIONALInicio: 8 de oct de 2025Fin estimado: 6 de ago de 2032

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

drug

Calderasib

Administered as an oral tablet

biological

Pembrolizumab (+) Berahyaluronidase alfa

Administered as a SC injection

drug

Pemetrexed

Administered as an IV Infusion

drug

Cisplatin

Administered as an IV Infusion

drug

Carboplatin

Administered as an IV Infusion

Ubicaciones

Instituto Alexander Fleming ( Site 0311)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +5491166936669

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +542234963224

RECRUITING

Hospital Italiano de Cordoba ( Site 0308)

Córdoba, Argentina

Study Coordinator · +543514106550

RECRUITING

CEMAIC ( Site 0309)

Córdoba, Argentina

Study Coordinator · +543513976568

RECRUITING

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

Contactos

Toll Free Number

CONTACT

Trialsites@msd.com 1-888-577-8839

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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