Estudio de fase III, aleatorizado, abierto y multicéntrico para evaluar la eficacia y seguridad de divarasib frente a sotorasib o adagrasib en pacientes con cáncer de pulmón de células no pequeñas avanzado o metastásico positivo para la mutación KRAS G12C previamente tratados

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06497556Tipo: INTERVENTIONALInicio: 23 de sept de 2024Fin estimado: 30 de nov de 2029

Resumen

El propósito de este estudio es evaluar la seguridad y eficacia de divarasib en comparación con los inhibidores de KRAS G12C aprobados localmente (sotorasib o adagrasib) en participantes con cáncer de pulmón de células no pequeñas (CPCNP) avanzado o metastásico positivo para KRAS G12C (KRAS G12C+).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Documentation of the presence of a KRAS G12C mutation
Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of \>= 12 weeks

Criterios de exclusión

Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
Malabsorption syndrome or other condition that would interfere with enteral absorption
Known concomitant second oncogenic driver
Mixed small-cell lung cancer or large cell neuroendocrine histology
Known and untreated, or active central nervous system (CNS) metastases
Leptomeningeal disease or carcinomatous meningitis
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
More than 30 Gy of radiotherapy to the lung within 6 months of randomization
Uncontrolled tumor-related pain
Unresolved toxicities from prior anticancer therapy
History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Intervenciones

drug

Divarasib

Divarasib will be administered orally QD

drug

Sotorasib

Sotorasib will be administered orally QD

drug

Adagrasib

Adagrasib will be administred orally BID

Ubicaciones

Hospital Britanico

Buenos Aires, Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

ColaboradorChugai Pharmaceutical

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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