An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

CompletadoFase 3ClinicalTrials.gov

ID: NCT02477826Tipo: INTERVENTIONALInicio: 5 de ago de 2015Fin estimado: 25 de oct de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria

Criterios de exclusión

Subjects with untreated Central nervous system (CNS) metastases are excluded
Subjects with an active, known or suspected autoimmune disease are excluded
Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection

Intervenciones

drug

Nivolumab

drug

Ipilimumab

drug

Carboplatin

drug

Cisplatin

drug

Gemcitabine

drug

Pemetrexed

drug

Paclitaxel

Ubicaciones

Local Institution - 0170

Berazategui, Buenos Aires, Argentina

Local Institution - 0171

Capital Federal, Buenos Aires, Argentina

Local Institution - 0172

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution - 0176

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0296

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0130

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0268

Córdoba, Argentina

Local Institution - 0272

Córdoba, Argentina

Local Institution - 0297

Córdoba, Argentina

Local Institution - 0177

Viedma, 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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