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
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Registration Number
- NCT06267001
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 56
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezolizumab + Tiragolumab Atezolizumab Participants will receive atezolizumab and tiragolumab intravenously (IV). Atezolizumab + Tiragolumab Tiragolumab Participants will receive atezolizumab and tiragolumab intravenously (IV). Atezolizumab + Placebo Atezolizumab Participants will receive atezolizumab and placebo IV. Atezolizumab + Placebo Placebo Participants will receive atezolizumab and placebo IV.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Up to approximately 2 years
- Secondary Outcome Measures
Name Time Method DFS Rate Year 3, Year 5, Year 7 Overall Survival (OS) Up to approximately 15 years Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab Up to approximately 1 year Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) Up to approximately 1 year Serum Concentration of Atezolizumab Up to approximately 1 year Percentage of Participants With Adverse Events (AEs) Up to approximately 15 years Percentage of Participants With ADAs to Atezolizumab Up to approximately 1 year Serum Concentration of Tiragolumab Up to approximately 1 year
Trial Locations
- Locations (163)
Ningbo No.2 Hospital
🇨🇳Ningbo, China
Instituto Europeo di Oncologia
🇮🇹Milano, Lombardia, Italy
Azienda U.S.L. 21 - Presidio Ospedaliero S. Spirito; U.O. Di Oncologia Clinica
🇮🇹Casale Monferrato, Piemonte, Italy
Ospedale Civile; Unita Operativa Di Oncologia Medica
🇮🇹Livorno, Toscana, Italy
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
🇪🇸Sevilla, Spain
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Florida Cancer Specialists - SOUTH - SCRI - PPDS
🇺🇸Fort Myers, Florida, United States
Centro Medico Dalinde
🇲🇽Cdmx, Mexico CITY (federal District), Mexico
SCRI Mark H. Zangmeister Center
🇺🇸Columbus, Ohio, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oncology Assoc of Oregon, PC
🇺🇸Eugene, Oregon, United States
TEXAS ONCOLOGY, P.A.; DEKE Slayton Cancer Center
🇺🇸Webster, Texas, United States
Hospital Britanico; Oncologia
🇦🇷Buenos Aires, Argentina
Hospital A. C. Camargo; Oncologia
🇧🇷Sao Paulo, SP, Brazil
Shandong Cancer Hospital
🇨🇳Jinan, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Yunnan Cancer Hospital
🇨🇳Kunming, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing City, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang City, China
The Affiliated Hospital Of Qingdao University
🇨🇳Qingdao City, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China
Liaoning Provincial Cancer Hospital
🇨🇳Shengyang, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan City, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
Metropolitan Hospital
🇬🇷Athens, Greece
Clinique Medico Chir Teissier; Pneumologie Soins Palliatifs
🇫🇷Valenciennes, France
Zhejiang Cancer Hospital
🇨🇳Zhejiang, China
Queen Mary Hospital; Centre of Cancer Medicine
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica
🇮🇹Varese, Lombardia, Italy
Humanitas Gavazzeni;U.O. Oncologia Medica
🇮🇹Bergamo, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Lombardia, Italy
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
Kyushu University Hospital
🇯🇵Fukuoka, Japan
National Cancer Center Hospital East
🇯🇵Chiba, Japan
Sendai Kousei Hospital
🇯🇵Miyagi, Japan
Fukushima Medical University Hospital
🇯🇵Miyagi, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
Kindai University Hospital
🇯🇵Osaka, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
St. Vincent's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Centro Oncologico Internacional
🇲🇽Mexico D.F., Mexico CITY (federal District), Mexico
Instituto Peruano de OncologÃa y Radioterapia
🇵🇪Lima, Peru
Clinica Sanchez Ferrer
🇵🇪Trujillo, Peru
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
🇵🇱Poznan, Poland
Instytut Gruzlicy I Chorob Pluc; Iii Klinika Chorob Pluc
🇵🇱Warszawa, Poland
Oncocenter Clinical Oncology
🇷🇴Timi?oara, Romania
Centrul de Oncologie Oncohelp
🇷🇴Timisoara, Romania
Hospital Provincial de Castellon; Servicio de Oncologia
🇪🇸Castellon de La Plana, Castellon, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Universitario San Cecilio; Servicio de Oncologia
🇪🇸Granada, Spain
Hospital Universitario La Paz; Servicio de Oncologia
🇪🇸Madrid, Spain
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
🇨🇳Kaohsiung, Taiwan
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
🇪🇸Sevilla, Spain
Tri-Service General Hospital; Dept. of Internal Medicine
🇨🇳Taipei, Taiwan
Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
🇹ðŸ‡Chang Mai, Thailand
Gazi Uni Medical Faculty Hospital; Oncology Dept
🇹🇷Ankara, Turkey
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
🇹🇷Bakirkoy / Istanbul, Turkey
Izmir Medical Point Hospital
🇹🇷Izmir, Turkey
Medical Park Seyhan Hospital
🇹🇷Seyhan, Turkey
Bilkent Sehir Hospita; ONKOLOJI
🇹🇷Çankaya/Ankara, Turkey
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Texas Oncology (Flower Mound) - USOR
🇺🇸Flower Mound, Texas, United States
Glendale Adventist Medical Ctr
🇺🇸Glendale, California, United States
Northwest Cancer Specialists - Vancouver
🇺🇸Vancouver, Washington, United States
Centro Oncologico Korben; Oncology
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
CHIREC
🇧🇪Auderghem, Belgium
Cancer Research SA
🇦🇺Adelaide, South Australia, Australia
Ulsan University Hosiptal
🇰🇷Ulsan, Korea, Republic of
Guangdong General Hospital
🇨🇳Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou City, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
ERRIKOS DYNAN HOSPITAL; 4th ONCOLOGY CLINIC
🇬🇷Athens, Greece
Nemocnica Svet zdravia Michalovce
🇸🇰Michalovce, Slovakia
Onco Card SRL, Centrul de Diagnostic si Tratament Oncologic Brasov
🇷🇴Brasov, Romania
Nemocnica na okraji mesta, n.o.; Ambulancia klinickej onkologie
🇸🇰Partizanske, Slovakia
Centro Oncologico de Galicia COG; Medical Oncology
🇪🇸A Coruna, LA Coruña, Spain
Hospital Universitario Son Espases; Servicio de Oncologia
🇪🇸Palma De Mallorca, Islas Baleares, Spain
National Taiwan Uni Hospital; Dept of Oncology
🇨🇳Taipei, Taiwan
VA Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Sanatorio Parque S.A.
🇦🇷Rosario, Argentina
AZ Groeninge
🇧🇪Kortrijk, Belgium
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Oita University Hospital
🇯🇵Oita, Japan
National Taiwan University Cancer Center
🇨🇳Zhongzheng Dist., Taiwan
Vajira Hospital
🇹ðŸ‡Bangkok, Thailand
Sanatorio Allende
🇦🇷Cordoba, Argentina
Jessa Zkh (Campus Virga Jesse)
🇧🇪Hasselt, Belgium
University Clinical Emergency Hospital Bucharest
🇷🇴Bucharest, Romania
Centrul de Radioterapie AMETHYST
🇷🇴Floresti, Romania
Chulalongkorn Hospital; Medical Oncology
🇹ðŸ‡Bangkok, Thailand
Eastern CT Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
🇨🇳Taipei, Taiwan
CHU HELORA - Hôpital de la Louvière - Site Jolimont
🇧🇪Haine-Saint-Paul, Belgium
Krakowski Szpital Specjalistyczny imsw. Jana Paw?a II; Diagnostyka onkologicznaguza klatkipiersiowej
🇵🇱Krakow, Poland
E-DA Hospital; Chest
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital; Dept of Internal Medicine
🇨🇳Taichung, Taiwan
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
🇹ðŸ‡Bangkok, Thailand
Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
🇪🇸Las Palmas de Gran Canaria, LAS Palmas, Spain
Ospedale P. Pederzoli Casa di cura Privata; Lung Unit Thoracic 3° Floor
🇮🇹Peschiera Del Garda (VR), Veneto, Italy
Accelerium S. de R.L. de C.V.
🇲🇽Monterrey, Nuevo LEON, Mexico
ARKE Estudios ClÃnicos S.A. de C.V.
🇲🇽Ciudad de México, Mexico
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
🇵🇱Olsztyn, Poland
Univerzitna nemocnica Bratislava; Oddelenie Klinickej Onkologie, Klinika Pneumologie A Ftizeologie
🇸🇰Bratislava, Slovakia
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
🇵🇱Gdansk, Poland
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
🇷🇴Cluj Napoca, Romania
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
🇪🇸Santander, Cantabria, Spain
Monash Health
🇦🇺Clayton, Victoria, Australia
The Oncology Institute of Hope and Innovation; Cerritos
🇺🇸Cerritos, California, United States
University of California, San Francisco; Medical Center
🇺🇸San Francisco, California, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
The Oncology Institute of Hope and Innovation - Florida
🇺🇸Fort Lauderdale, Florida, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
🇺🇸Marietta, Georgia, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Ascension Saint Agnes
🇺🇸Baltimore, Maryland, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
UNM Lovelace
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Asante Rogue Regional Medical Center
🇺🇸Medford, Oregon, United States
Texas Oncology (Worth) - USOR
🇺🇸Dallas, Texas, United States
Texas Oncology, P.A.; San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Renovatio Clinical
🇺🇸The Woodlands, Texas, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
UZ Gent
🇧🇪Gent, Belgium
Oncoclinicas Rio de Janeiro S.A.
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital de ClÃnicas de Passo Fundo; Centro de Pesquisa em Oncologia
🇧🇷Passo Fundo, RS, Brazil
Changzhou First People's Hospital; Oncology
🇨🇳Changzhou, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Cancer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Greenslopes Private Hospital; Gallipoli Research Centre
🇦🇺Greenslopes, Queensland, Australia
James A. Haley Veterans Hospital
🇺🇸Tampa, Florida, United States
Woodlands Medical Specialists, P.A.
🇺🇸Pensacola, Florida, United States
Virginia Cancer Specialists (Fairfax) - USOR
🇺🇸Fairfax, Virginia, United States
Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States
Arizona Oncology Associates, PC - NAHOA
🇺🇸Prescott, Arizona, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
🇺🇸Billings, Montana, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Hospital Sao Domingos
🇧🇷Sao Luis, MA, Brazil
Nucleo de Oncologia da Bahia - NOB
🇧🇷Salvador, Bahia, Bahia, Brazil
Crio - Centro Regional Integrado de Oncologia
🇧🇷Fortaleza, Ceará, Brazil
Real Hospital Portugues de Beneficencia
🇧🇷Recife, Pernambuco, Brazil
Centro Oncologico Korben
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Sunshine Coast University Hospital
🇦🇺Birtinya, Queensland, Australia
Sunshine Coast University Hospital; The Adem Crosby Centre
🇦🇺Birtinya, Queensland, Australia
Hospital de ClÃnicas de Passo Fundo
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Hospital A. C. Camargo
🇧🇷Sao Paulo, São Paulo, Brazil
Changzhou First People's Hospital
🇨🇳Changzhou, China