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

NCT ID: NCT06267001

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Non-small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atezolizumab + Tiragolumab

Participants will receive atezolizumab and tiragolumab intravenously (IV).

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered IV.

Tiragolumab

Intervention Type DRUG

Tiragolumab will be administered IV.

Atezolizumab + Placebo

Participants will receive atezolizumab and placebo IV.

Group Type PLACEBO_COMPARATOR

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered IV.

Placebo

Intervention Type DRUG

Placebo will be administered IV.

Interventions

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Atezolizumab

Atezolizumab will be administered IV.

Intervention Type DRUG

Tiragolumab

Tiragolumab will be administered IV.

Intervention Type DRUG

Placebo

Placebo will be administered IV.

Intervention Type DRUG

Other Intervention Names

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Tecentriq; RO5541267 MTIG7192A; RO7092284

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Site Status

Monash Health

Clayton, Victoria, Australia

Site Status

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Site Status

Nucleo de Oncologia da Bahia - NOB

Salvador, Bahia, Estado de Bahia, Brazil

Site Status

Hospital de Clínicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Site Status

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Site Status

Hospital A. C. Camargo

São Paulo, São Paulo, Brazil

Site Status

Changzhou First People's Hospital

Changzhou, , China

Site Status

Guangdong General Hospital

Guangzhou, , China

Site Status

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, , China

Site Status

Shandong Cancer Hospital

Jinan, , China

Site Status

Yunnan Cancer Hospital

Kunming, , China

Site Status

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

Nanjing, , China

Site Status

Ningbo No.2 Hospital

Ningbo, , China

Site Status

Liaoning Provincial Cancer Hospital

Shengyang, , China

Site Status

Tianjin Cancer Hospital

Tianjin, , China

Site Status

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

Site Status

Zhejiang Cancer Hospital

Zhejiang, , China

Site Status

Ospedale P. Pederzoli Casa di cura Privata

Peschiera Del Garda (VR), Veneto, Italy

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

Kindai University Hospital

Osaka, , Japan

Site Status

Instytut Gruzlicy I Chorob Pluc

Warsaw, , Poland

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status

St. Vincent's Hospital

Gyeonggi-do, , South Korea

Site Status

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

E-DA Hospital

Kaohsiung City, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Taiwan University Cancer Center

Zhongzheng Dist., , Taiwan

Site Status

Vajira Hospital

Bangkok, , Thailand

Site Status

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

Bakirkoy / Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Argentina Australia Brazil China Italy Japan Poland South Korea Taiwan Thailand Turkey (Türkiye)

Other Identifiers

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2023-506696-10-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

GO45006

Identifier Type: -

Identifier Source: org_study_id

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