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COMPLETED
NCT04619797
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Atezolizumab

Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

DRUG

Pemetrexed

Pemetrexed 500 milligrams per square meter (mg/m\^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

DRUG

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.

DRUG

Cisplatin

Cisplatin 75 mg/m\^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.

DRUG

Tiragolumab Matching Placebo

Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

DRUG

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

And 27 more locations on ClinicalTrials.gov