A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

CompletadoFase 3ClinicalTrials.gov

ID: NCT04026412Tipo: INTERVENTIONALInicio: 8 de oct de 2019Fin estimado: 26 de nov de 2024

Traducción no disponible, mostrando original

Resumen

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

Criterios de exclusión

Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
Active infection requiring systemic therapy within 14 days prior to randomization
History of organ or tissue transplant that requires systemic use of immune suppressive agents
Prior thoracic radiotherapy

Intervenciones

biological

nivolumab

Specified dose on specified days

biological

ipilimumab

Specified dose on specified days

biological

durvalumab

Specified dose on specified days

Ubicaciones

Local Institution - 0044

CABA, Buenos Aires, Argentina

Local Institution - 0045

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0043

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0042

Caba, Distrito Federal, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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