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A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: * Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin * Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).
Official title: A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
542
Start Date
2020-12-15
Completion Date
2025-11-20
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Pemetrexed
Pemetrexed 500 milligrams per square meter (mg/m\^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Cisplatin
Cisplatin 75 mg/m\^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Tiragolumab Matching Placebo
Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Pembrolizumab
Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.
Locations (127)
UCLA
Los Angeles, California, United States
PIH Health Whittier Hospital
Whittier, California, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
SCRI Florida Cancer Specialists North
St. Petersburg, Florida, United States
Advent Health Orlando
Winter Park, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
AZORG Campus Aalst-Moorselbaan
Aalst, Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium
CHU UCL Mont-Godinne
Mont-godinne, Belgium
Vitaz
Sint-Niklaas, Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Oncocentro Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Beijing Cancer Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
Xiangya Hospital Central South University
Changsha, China
Affiliated Hospital of Chengde Medical University
Chengde, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital - Sichuan University
Chengdu, China
Anhui Provincial Hospital
Hefei, China
Jinan Central Hospital
Jinan, China
Pingxiang People's Hospital
Pingxiang, China
Qingdao Central Hospital
Qingdao, China
Weifang People's Hospital
Weifang, China
Hubei Cancer Hospital
Wuhan, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Rigshospitalet
København Ø, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, Denmark
Institut Bergonie
Bordeaux, France
Hopital Nord
Marseille, France
Hopital de Pontchaillou
Rennes, France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, France
CHU de Toulouse - Hôpital Larrey
Toulouse, France
Helios Klinikum Emil von Behring GmbH
Berlin, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
St. Vincentius Kliniken Karlsruhe
Karlsruhe, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz, Germany
Klinikum der Philipps-Universität Marburg
Marburg, Germany
Hong Kong United Oncology Centre
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Centro Di Riferimento Oncologico
Aviano, Friuli Venezia Giulia, Italy
A.O. Villa Scassi
Genoa, Liguria, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Kyushu University Hospital
Fukuoka, Japan
Kurume University Hospital
Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Japan
Takarazuka City Hospital
Hyōgo, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan
Sendai Kousei Hospital
Miyagi, Japan
Osaka International Cancer Institute
Osaka, Japan
Kansai Medical University Hospital
Osaka, Japan
Kindai University Hospital
Osaka, Japan
NHO Kinki Chuo Chest Medical Center
Osaka, Japan
Saitama Cancer Center
Saitama, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Cuidados oncologicos
Querétaro City, Querétaro, Mexico
Oncologico Potosino
San Luis Potosí City, San Luis Potosí, Mexico
ARKE Estudios Clínicos S.A. de C.V.
Mexico City, Mexico
Auckland City Hospital, Cancer and Blood Research
Auckland, New Zealand
Waikato Hospital - Cancer and Blood Research Trials Unit
Hamilton, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
Lódz, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, Poland
Kosin University Gospel Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
St. Vincent's Hospital
Gyeonggi-do, South Korea
Samsung Changwon Hospital
Gyeongsangnam-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Seoul St Mary's Hospital
Seoul, South Korea
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario Insular?Materno Infantil
Las Palmas de Gran Canaria, LAS Palmas, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Hospital Lucus Augusti
Lugo, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain