A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT02008227Tipo: INTERVENTIONALInicio: 11 de mar de 2014Fin estimado: 9 de ene de 2019

Traducción no disponible, mostrando original

Resumen

This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Criterios de exclusión

Known active or untreated central nervous system (CNS) metastases
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
History of autoimmune disease
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Active hepatitis B or hepatitis C
Prior treatment with docetaxel
Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Intervenciones

drug

Atezolizumab

1200 mg IV infusion on Day 1 of each 21-day cycle

drug

Docetaxel

75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle

Ubicaciones

Instituto Medico Rio Cuarto

Córdoba, Argentina

COIBA

Provincia de Buenos Aires, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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