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A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy
A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

NCT06267001

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Atezolizumab, Tiragolumab, Placebo

Countries: Argentina, Australia, Brazil, China, Italy, Japan, Poland, South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
Locations (37)
  • Ciudad Autonoma Buenos Aires, Argentina
  • Birtinya, Queensland, Australia
  • Clayton, Victoria, Australia
  • Fortaleza, Ceará, Brazil
  • Salvador, Bahia, Estado de Bahia, Brazil
  • Passo Fundo, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Barretos, São Paulo, Brazil
  • Changzhou, China
  • Guangzhou, China
  • Jinan, China
  • Kunming, China
  • Nanjing, China
  • Ningbo, China
  • Shengyang, China
  • Tianjin, China
  • Wuhan, China
  • Zhejiang, China
  • Peschiera Del Garda (VR), Veneto, Italy
  • Hiroshima, Japan
  • Osaka, Japan
  • Warsaw, Poland
  • Busan, South Korea
  • Daegu, South Korea
  • Gyeonggi-do, South Korea
  • Gyeongsangnam-do, South Korea
  • Seongnam-si, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • + 7 more on CT.gov