A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT02367794Tipo: INTERVENTIONALInicio: 11 de jun de 2015Fin estimado: 17 de feb de 2021

Traducción no disponible, mostrando original

Resumen

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
Measurable disease as defined by RECIST v1.1
Adequate hematologic and end organ function

Criterios de exclusión

Active or untreated central nervous system (CNS) metastasis
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Pregnant or lactating women
History of autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Positive test for Human Immunodeficiency Virus (HIV)
Active hepatitis B or hepatitis C
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
Severe infection within 4 weeks prior to randomization
Significant history of cardiovascular disease

Intervenciones

drug

Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody

Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.

drug

Carboplatin

Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.

drug

Nab-Paclitaxel

Nab-paclitaxel 100 milligrams per meter squared (mg/m\^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

drug

Paclitaxel

Paclitaxel 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m\^2 IV.

Ubicaciones

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Clínica Pergamino

Pergamino, Argentina

Fundacion Koriza

Santa Rosa, Argentina

Centro de Investigacion; Clinica - Clinica Viedma S.A.

Viedma, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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.

A Phase III, Open-Label, Multicenter, Randomized Study Ev... | EligiMed