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
NCT ID: NCT04619797
Last Updated: 2025-12-17
Study Results
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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COMPLETED
PHASE2/PHASE3
542 participants
INTERVENTIONAL
2020-12-15
2025-11-20
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin
Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.
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.
Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin
Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
* No prior systemic treatment for metastatic non-squamous NSCLC
* Known tumor programmed death-ligand 1 (PD-L1) status
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
* Life expectancy \>= 12 weeks
* Adequate hematologic and end-organ function
* Negative human immunodeficiency virus (HIV) test at screening
* Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.
Exclusion Criteria
* Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
* History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death
* Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
* Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
* Women who are pregnant, or breastfeeding
* Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Medeniyet University Goztepe Training and Research Hospital.
Kadiköy, , Turkey (Türkiye)
Castle Hill Hospital
Hull, , United Kingdom
Barts & London School of Med
London, , United Kingdom
Guy'S Hospital
London, , United Kingdom
Christie Hospital Nhs Trust
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
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
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
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
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
Hospital Universitario La Paz
Madrid, , Spain
Hospital Univ. Nuestra Señora de Valme
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Kantonsspital Aarau
Aarau, , Switzerland
Kantonsspital Graubünden Medizin Onkologie
Chur, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
Changhua Christian Hospital
Chang-hua, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Vajira Hospital
Bangkok, , Thailand
Chulalongkorn Hospital
Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Adana Baskent University Medical Faculty
Adana, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2020-002851-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502031-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
BO42592
Identifier Type: -
Identifier Source: org_study_id