A Phase III, Randomized, Double-blind Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT06267001Tipo: INTERVENTIONALInicio: 21 de mar de 2024Fin estimado: 16 de dic de 2025

Traducción no disponible, mostrando original

Resumen

The purpose of this study was to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.

Descripción detallada

With Protocol Amendment 2, enrollment will be stopped. The primary objective of the study has been changed to a safety objective and no other analysis will be conducted

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology
Participants must have had complete resection of NSCLC
Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy
Participants must have recovered adequately from surgery and from adjuvant chemotherapy
Tumor cell PD-L1 expression at \>/= 1%
Adequate hematologic and end-organ function.

Criterios de exclusión

Any history of prior NSCLC within the last 5 years
Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy
NSCLC known to have mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene

Intervenciones

drug

Atezolizumab

Atezolizumab will be administered IV.

drug

Tiragolumab

Tiragolumab will be administered IV.

drug

Placebo

Placebo will be administered IV.

Ubicaciones

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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