Estudio adaptativo de fase III, multicéntrico, aleatorizado, abierto y controlado de M7824 (bintrafusp alfa) versus pembrolizumab como tratamiento de primera línea en pacientes con cáncer de pulmón de células no pequeñas avanzado con expresión de PD-L1

CompletadoFase 3ClinicalTrials.gov

ID: NCT03631706Tipo: INTERVENTIONALInicio: 1 de oct de 2018Fin estimado: 25 de jun de 2024

Resumen

El propósito del estudio es evaluar la eficacia y seguridad de bintrafusp alfa (M7824) en comparación con pembrolizumab en participantes con NSCLC avanzado con alta expresión tumoral de PD-L1, sin mutación del receptor del factor de crecimiento epidérmico (EGFR) ni translocación de la quinasa de linfoma anaplásico (ALK). El diseño adaptativo de Fase III permite la opción de reclutar hasta 584 pacientes conforme a reglas preespecificadas.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed diagnosis of advanced NSCLC
Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
Have measurable disease based on RECIST 1.1
Have a life expectancy of at least 3 months
Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
PD-L1 high status as determined by central testing

Criterios de exclusión

Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study
Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations
Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years

Intervenciones

drug

M7824

Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.

drug

Pembrolizumab

Pembrolizumab: Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.

Ubicaciones

Centro de Oncologia e Investigacion Buenos Aires

Berazategui, Argentina

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Centro Medico San Roque S.R.L.

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalEMD Serono Research & Development Institute, Inc.

ColaboradorMerck KGaA, Darmstadt, Germany

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