Un estudio de fase III, aleatorizado y abierto para evalu... | EligiMed

Un estudio de fase III, aleatorizado y abierto para evaluar la eficacia y seguridad de divarasib y pembrolizumab versus pembrolizumab y pemetrexed y carboplatino o cisplatino en pacientes con cáncer de pulmón de células no pequeñas no escamoso (CPNCP), avanzado o metastásico, con mutación KRAS G12C, sin tratamiento previo.

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06793215Tipo: INTERVENTIONALInicio: 24 de oct de 2025Fin estimado: 31 de oct de 2030

Resumen

El propósito de este estudio es evaluar la eficacia y seguridad de divarasib y pembrolizumab en comparación con pembrolizumab y pemetrexed y carboplatino o cisplatino, para el tratamiento de primera línea de participantes adultos con CPNCP no escamoso, avanzado o metastásico, con mutación KRAS G12C.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
Measurable disease, as defined by RECIST v1.1
No prior systemic treatment for advanced or metastatic NSCLC
Documentation of the presence of a KRAS G12C mutation
Documentation of known PD-L1 expression status in tumor tissue
Availability of a representative tumor specimen
Adequate end-organ function
Eligible to receive a platinum-based chemotherapy regimen

Criterios de exclusión

Known concomitant second oncogenic driver with available targeted treatment
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to randomization
History of leptomeningeal disease
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study
Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung \>30Gy within 6 months prior to randomization
Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors
Current treatment with medications that are well known to prolong the QT interval
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization
Prior allogeneic stem cell or solid organ transplantation
History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \[OS\] rate \>90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
Significant cardiovascular disease within 3 months prior to screening

Intervenciones

drug

Divarasib

Divarasib will be administered orally QD

drug

Pembrolizumab

Pembrolizumab will be administered via IV infusion Q3W

drug

Pemetrexed

Pemetrexed will be administered via IV infusion Q3W

drug

Carboplatin

Carboplatin will be administered via IV infusion Q3W

drug

Cisplatin

Cisplatin will be administered via IV infusion Q3W

Ubicaciones

Hospital Britanico

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

ColaboradorChugai Pharmaceutical

Contactos

Reference Study ID Number: CO45042 https://forpatients.roche.com/

CONTACT

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada)

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.