Patrocinado por: Hoffmann-La Roche
Status de recrutamento
Faixa etária
Sexo
Fase do estudo
Este é um estudo randomizado, duplo-cego desenhado para avaliar a eficácia, segurança, farmacocinética e imunogenicidade do tratamento neoadjuvante com atezolizumabe (MPDL3280A) ou placebo em combinação com quimioterapia à base de platina em participantes com Estágio II ressecável, IIIA ou IIIB selecionado câncer de pulmão de células não pequenas (NSCLC) seguido por adjuvante aberto/atezolizumabe pós-operatório ou melhor tratamento de suporte e monitoramento.
Critérios de inclusão:
Critérios de exclusão:
Atezolizumab will be administered as intravenous (IV) infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle (every 3 weeks) for 4 cycles during the neoadjuvant treatment phase Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) every 3 weeks for 16 cycles during the post-operative adjuvant phase
Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Nab-paclitaxel 100 mg/m^2 will be administered intravenously on Days 1, 8, and 15 of each 21 day cycle for 4 cycles during the neoadjuvant treatment phase
Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Carboplatin initial target AUC of 6 mg/mL/min will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Cisplatin 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Gemcitabine 1250 mg/m^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
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