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 | Completed Phase 3 FDA Drug

• 2 other identifiers: GO450062023-506696-10-00
• Study Type: interventional
• Target: 56
• Locations: 11 countries
• Sites: 39

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  Up to approximately 2 years

Study Arms (2)

Atezolizumab + Tiragolumab

EXPERIMENTAL

Participants will receive atezolizumab and tiragolumab intravenously (IV).

Drug: Atezolizumab; Drug: Tiragolumab

Atezolizumab + Placebo

PLACEBO COMPARATOR

Participants will receive atezolizumab and placebo IV.

Drug: Atezolizumab; Drug: Placebo

Interventions

Atezolizumab DRUG

Atezolizumab will be administered IV.

Also known as: Tecentriq; RO5541267

Atezolizumab + Placebo; Atezolizumab + Tiragolumab

Tiragolumab DRUG

Tiragolumab will be administered IV.

Also known as: MTIG7192A; RO7092284

Atezolizumab + Tiragolumab

Placebo DRUG

Placebo will be administered IV.

Atezolizumab + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (39)

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60336-232, Brazil

Location

Nucleo de Oncologia da Bahia - NOB

Salvador, Bahia, Estado de Bahia, 40170-380, Brazil

Location

Hospital de Clínicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Hospital A. C. Camargo

São Paulo, São Paulo, 01509-010, Brazil

Location

Changzhou First People's Hospital

Changzhou, 213003, China

Location

Guangdong General Hospital

Guangzhou, 510080, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510080, China

Location

Shandong Cancer Hospital

Jinan, 250117, China

Location

Yunnan Cancer Hospital

Kunming, 650118, China

Location

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, 210008, China

Location

Ningbo No.2 Hospital

Ningbo, DUMMY_VALUE, China

Location

Liaoning Provincial Cancer Hospital

Shengyang, 110042, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030, China

Location

Zhejiang Cancer Hospital

Zhejiang, 310022, China

Location

Ospedale P. Pederzoli Casa di cura Privata

Peschiera Del Garda (VR), Veneto, 37019, Italy

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Kindai University Hospital

Osaka, 589-8511, Japan

Location

Instytut Gruzlicy I Chorob Pluc

Warsaw, 01-138, Poland

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

St. Vincent's Hospital

Gyeonggi-do, 16247, South Korea

Location

Pusan National University Yangsan Hospital

Gyeongsangnam-do, 50612, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

E-DA Hospital

Kaohsiung City, 824, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Taiwan University Cancer Center

Zhongzheng Dist., 106, Taiwan

Location

Vajira Hospital

Bangkok, 10300, Thailand

Location

Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

Bakirkoy / Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; Tiragolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: March 21, 2024
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\ and\ development/who\ we\ are\ how\ we\ work/clinical\ trials/our\ commitment\ to\ data\ sharing.htm).

Locations

CN (11); AU (2); AR (1); BR (6); IT (1); JP (2); TH (1); KR (10); PL (1); TW (3); TU (1)