An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT02041533Tipo: INTERVENTIONALInicio: 27 de mar de 2014Fin estimado: 27 de may de 2022

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
PD-L1+ on immunohistochemistry testing performed by central lab
Men and women, ages ≥ 18 years of age

Criterios de exclusión

Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
Known anaplastic lymphoma kinase (ALK) translocations
Untreated central nervous system (CNS) metastases
Previous malignancies
Active, known or suspected autoimmune disease

Intervenciones

biological

Nivolumab

drug

Gemcitabine

drug

Cisplatin

drug

Carboplatin

drug

Paclitaxel

drug

Pemetrexed

Ubicaciones

Local Institution - 0051

Berazategui, Buenos Aires, Argentina

Local Institution - 0049

Capital Federal, Buenos Aires, Argentina

Local Institution - 0052

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution - 0048

Córdoba, Argentina

Local Institution - 0050

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorOno Pharmaceutical Co. Ltd

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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