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

Trial Title: 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

Condition: Non-small Cell Lung Cancer (NSCLC)

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Atezolizumab

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Atezolizumab
Description: Atezolizumab will be administered IV.
Arm group label: Atezolizumab + Placebo
Arm group label: Atezolizumab + Tiragolumab

Other name: Tecentriq; RO5541267

Intervention type: Drug
Intervention name: Tiragolumab
Description: Tiragolumab will be administered IV.
Arm group label: Atezolizumab + Tiragolumab

Other name: MTIG7192A; RO7092284

Intervention type: Drug
Intervention name: Placebo
Description: Placebo will be administered IV.
Arm group label: Atezolizumab + Placebo

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.

Detailed description: 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

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The Oncology Institute of Hope and Innovation; Cerritos

Address:
City: Cerritos
Zip: 90703
Country: United States

Facility:
Name: Springfield Clinic

Address:
City: Springfield
Zip: 62702
Country: United States

Facility:
Name: Hospital Britanico; Oncologia

Address:
City: Buenos Aires
Zip: C1280AEB
Country: Argentina

Facility:
Name: CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC

Address:
City: Ciudad Autonoma Buenos Aires
Zip: C1056ABI
Country: Argentina

Facility:
Name: Centro Oncologico Korben; Oncology

Address:
City: Ciudad Autonoma Buenos Aires
Zip: C1426AGE
Country: Argentina

Facility:
Name: Sanatorio Allende

Address:
City: Cordoba
Zip: X5000JHQ
Country: Argentina

Facility:
Name: Sanatorio Parque S.A.

Address:
City: Rosario
Zip: S2000QGB
Country: Argentina

Facility:
Name: Sunshine Coast University Hospital; The Adem Crosby Centre

Address:
City: Birtinya
Zip: 4575
Country: Australia

Facility:
Name: Monash Health

Address:
City: Clayton
Zip: 3168
Country: Australia

Facility:
Name: Nucleo de Oncologia da Bahia - NOB

Address:
City: Salvador, Bahia
Zip: 40170-380
Country: Brazil

Facility:
Name: Crio - Centro Regional Integrado de Oncologia

Address:
City: Fortaleza
Zip: 60336-232
Country: Brazil

Facility:
Name: Real Hospital Portugues de Beneficencia

Address:
City: Recife
Zip: 52010-075
Country: Brazil

Facility:
Name: Oncoclinicas Rio de Janeiro S.A.

Address:
City: Rio de Janeiro
Zip: 22250-905
Country: Brazil

Facility:
Name: Hospital de Clínicas de Passo Fundo; Centro de Pesquisa em Oncologia

Address:
City: Passo Fundo
Zip: 99010-260
Country: Brazil

Facility:
Name: Hospital Nossa Senhora da Conceicao

Address:
City: Porto Alegre
Zip: 90040-373
Country: Brazil

Facility:
Name: Hospital de Cancer de Barretos

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

Facility:
Name: Hospital A. C. Camargo; Oncologia

Address:
City: Sao Paulo
Zip: 01509-010
Country: Brazil

Facility:
Name: Changzhou First People's Hospital; Oncology

Address:
City: Changzhou
Zip: 213003
Country: China

Facility:
Name: West China Hospital, Sichuan University

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: The First Affiliated Hospital of Sun Yat-sen University

Address:
City: Guangzhou City
Zip: 510080
Country: China

Facility:
Name: Guangdong General Hospital

Address:
City: Guangzhou
Zip: 510080
Country: China

Facility:
Name: Anhui Provincial Hospital

Address:
City: Hefei
Zip: 230001
Country: China

Facility:
Name: Shandong Cancer Hospital

Address:
City: Jinan
Zip: 250117
Country: China

Facility:
Name: Yunnan Cancer Hospital

Address:
City: Kunming
Zip: 650118
Country: China

Facility:
Name: The First Affiliated Hospital of Nanchang University

Address:
City: Nanchang City
Zip: 330008
Country: China

Facility:
Name: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Address:
City: Nanjing City
Zip: 210008
Country: China

Facility:
Name: Ningbo No.2 Hospital

Address:
City: Ningbo
Country: China

Facility:
Name: The Affiliated Hospital Of Qingdao University

Address:
City: Qingdao City
Zip: 266031
Country: China

Facility:
Name: Zhongshan Hospital Fudan University

Address:
City: Shanghai
Zip: 200032
Country: China

Facility:
Name: Shanghai Pulmonary Hospital

Address:
City: Shanghai
Zip: 200433
Country: China

Facility:
Name: Liaoning Provincial Cancer Hospital

Address:
City: Shengyang
Zip: 110042
Country: China

Facility:
Name: Tianjin Cancer Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Facility:
Name: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Address:
City: Wuhan City
Zip: 430030
Country: China

Facility:
Name: The Affiliated Hospital of Xuzhou Medical University

Address:
City: Xuzhou
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Zhejiang
Zip: 310022
Country: China

Facility:
Name: The First Affiliated Hospital of Zhengzhou University

Address:
City: Zhengzhou
Zip: 450052
Country: China

Facility:
Name: Clinique Medico Chir Teissier; Pneumologie Soins Palliatifs

Address:
City: Valenciennes
Zip: 59326
Country: France

Facility:
Name: Instituto Europeo di Oncologia

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Ospedale P. Pederzoli Casa di cura Privata; Lung Unit Thoracic 3° Floor

Address:
City: Peschiera Del Garda (VR)
Zip: 37019
Country: Italy

Facility:
Name: National Cancer Center Hospital East

Address:
City: Chiba
Zip: 277-8577
Country: Japan

Facility:
Name: Kyushu University Hospital

Address:
City: Fukuoka
Zip: 812-8582
Country: Japan

Facility:
Name: Hiroshima University Hospital

Address:
City: Hiroshima
Zip: 734-8551
Country: Japan

Facility:
Name: Fukushima Medical University Hospital

Address:
City: Miyagi
Zip: 960-1295
Country: Japan

Facility:
Name: Sendai Kousei Hospital

Address:
City: Miyagi
Zip: 981-0914
Country: Japan

Facility:
Name: Oita University Hospital

Address:
City: Oita
Zip: 879-5593
Country: Japan

Facility:
Name: Okayama University Hospital

Address:
City: Okayama
Zip: 700-8558
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Osaka
Zip: 589-8511
Country: Japan

Facility:
Name: Saitama Cancer Center

Address:
City: Saitama
Zip: 362-0806
Country: Japan

Facility:
Name: Juntendo University Hospital

Address:
City: Tokyo
Zip: 113-8431
Country: Japan

Facility:
Name: The Cancer Institute Hospital of JFCR

Address:
City: Tokyo
Zip: 135-8550
Country: Japan

Facility:
Name: Pusan National University Hospital

Address:
City: Busan
Zip: 602-739
Country: Korea, Republic of

Facility:
Name: Chungbuk National University Hospital

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

Facility:
Name: Kyungpook National University Chilgok Hospital

Address:
City: Daegu
Zip: 41404
Country: Korea, Republic of

Facility:
Name: St. Vincent's Hospital

Address:
City: Gyeonggi-do
Zip: 16247
Country: Korea, Republic of

Facility:
Name: Pusan National University Yangsan Hospital

Address:
City: Gyeongsangnam-do
Zip: 50612
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Jeollanam-do
Zip: 58128
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si
Zip: 463-707
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Korea University Guro Hospital

Address:
City: Seoul
Zip: 08308
Country: Korea, Republic of

Facility:
Name: Ulsan University Hosiptal

Address:
City: Ulsan
Zip: 44033
Country: Korea, Republic of

Facility:
Name: Instituto Peruano de Oncología y Radioterapia

Address:
City: Lima
Zip: 15072
Country: Peru

Facility:
Name: Instytut Gruzlicy I Chorob Pluc; Iii Klinika Chorob Pluc

Address:
City: Warszawa
Zip: 01-138
Country: Poland

Facility:
Name: Univerzitna nemocnica Bratislava; Oddelenie Klinickej Onkologie, Klinika Pneumologie A Ftizeologie

Address:
City: Bratislava
Zip: 826 06
Country: Slovakia

Facility:
Name: Nemocnica Svet zdravia Michalovce

Address:
City: Michalovce
Zip: 071 01
Country: Slovakia

Facility:
Name: Nemocnica na okraji mesta, n.o.; Ambulancia klinickej onkologie

Address:
City: Partizanske
Zip: 958 01
Country: Slovakia

Facility:
Name: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Address:
City: Santander
Zip: 39008
Country: Spain

Facility:
Name: Hospital Provincial de Castellon; Servicio de Oncologia

Address:
City: Castellon de La Plana
Zip: 12002
Country: Spain

Facility:
Name: Hospital Universitario Son Espases; Servicio de Oncologia

Address:
City: Palma De Mallorca
Zip: 07014
Country: Spain

Facility:
Name: Centro Oncologico de Galicia COG; Medical Oncology

Address:
City: A Coruna
Zip: 15009
Country: Spain

Facility:
Name: Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia

Address:
City: Las Palmas de Gran Canaria
Zip: 35016
Country: Spain

Facility:
Name: Hospital Universitario San Cecilio; Servicio de Oncologia

Address:
City: Granada
Zip: 18003
Country: Spain

Facility:
Name: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Address:
City: Madrid
Zip: 28009
Country: Spain

Facility:
Name: Hospital Universitario La Paz; Servicio de Oncologia

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

Address:
City: Sevilla
Zip: 41014
Country: Spain

Facility:
Name: Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: E-DA Hospital; Chest

Address:
City: Kaohsiung
Zip: 824
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital; Dept of Internal Medicine

Address:
City: Taichung
Zip: 407
Country: Taiwan

Facility:
Name: National Taiwan Uni Hospital; Dept of Oncology

Address:
City: Taipei
Zip: 100
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

Address:
City: Taipei
Zip: 112
Country: Taiwan

Facility:
Name: Tri-Service General Hospital; Dept. of Internal Medicine

Address:
City: Taipei
Zip: 114
Country: Taiwan

Facility:
Name: National Taiwan University Cancer Center

Address:
City: Zhongzheng Dist.
Zip: 106
Country: Taiwan

Facility:
Name: Vajira Hospital

Address:
City: Bangkok
Zip: 10300
Country: Thailand

Facility:
Name: Gazi Uni Medical Faculty Hospital; Oncology Dept

Address:
City: Ankara
Zip: 06500
Country: Turkey

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

Address:
City: Bakirkoy / Istanbul
Zip: 34147
Country: Turkey

Facility:
Name: Izmir Medical Point Hospital

Address:
City: Izmir
Zip: 35101
Country: Turkey

Facility:
Name: Medical Park Seyhan Hospital

Address:
City: Seyhan
Zip: 01140
Country: Turkey

Facility:
Name: Bilkent Sehir Hospita; ONKOLOJI

Address:
City: Çankaya/Ankara
Zip: 06800
Country: Turkey

Start date: March 21, 2024

Completion date: December 31, 2025

Lead sponsor:
Agency: Hoffmann-La Roche
Agency class: Industry

Source: Hoffmann-La Roche

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06267001