Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

CompletadoFase 3ClinicalTrials.gov

ID: NCT02998528Tipo: INTERVENTIONALInicio: 4 de mar de 2017Fin estimado: 6 de dic de 2024

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Resumen

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
Lung function capacity capable of tolerating the proposed lung surgery
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Available tissue of primary lung tumor

Criterios de exclusión

Presence of locally advanced, inoperable or metastatic disease
Participants with active, known or suspected autoimmune disease
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)