NCT04619797CompletedPhase 2/3
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
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
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 542 (actual)
- First submitted
- 30 Oct 2020
- Start date
- 15 Dec 2020
- Primary completion date
- 19 Apr 2024
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Lung cancer
- NCT number
- NCT04619797
- EU CT number
- 2022-502031-20-00
- EudraCT number
- 2020-002851-39
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 542
- From 15 Dec 2020 to the primary completion date, 19 Apr 2024
- 127 sites in 21 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
- Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
Lab values
- Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
- 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
Other
- Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Women who are pregnant, or breastfeeding
- Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (127)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Onze-Lieve-Vrouwziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Completed |
| UCL Mont-Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Completed |
| Hospital de Cancer de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Oncocentro Belo Horizonte Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Crio - Centro Regional Integrado de Oncologia Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Hospital Nossa Senhora da Conceição Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital das Clinicas - UFRGS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto do Cancer do Estado de Sao Paulo - ICESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Royal Victoria Regional Health Centre Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Lakeridge Health Oshawa Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Sault Area Hospital Coordinator of this site? Confirm its status | Sault Ste. Marie | Canada | Unknown status |
| Kantonsspital Aarau Coordinator of this site? Confirm its status | Aarau | Switzerland | Unknown status |
| Kantonsspital Graubünden Medizin Onkologie Coordinator of this site? Confirm its status | Chur | Switzerland | Unknown status |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Affiliated Hospital of Chengde Medical University Coordinator of this site? Confirm its status | Chengde | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Qingdao Central Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Weifang People's Hospital Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Xian Jiao Tong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Helios Klinikum Emil von Behring GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Completed |
| Vincentius-Diakonissen-Kliniken gAG Coordinator of this site? Confirm its status | Karlsruhe | Germany | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Marburg | Germany | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Completed |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Completed |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Castle Hill Hospital Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts & London School of Med Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Christie Hospital NHS Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| New Cross Hospital Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| Hong Kong United Oncology Centre Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Tuen Mun Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| Centro di Riferimento Oncologico Coordinator of this site? Confirm its status | Aviano | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| A.O. Villa Scassi Coordinator of this site? Confirm its status | Genoa | Italy | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Takarazuka City Hospital Coordinator of this site? Confirm its status | Hyōgo | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Sendai Kousei Hospital Coordinator of this site? Confirm its status | Miyagi | Japan | Unknown status |
| NHO Kinki-Chuo Chest Medical Center Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Saitama Cancer Center Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| St. Vincent's Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Samsung Changwon Hospital Coordinator of this site? Confirm its status | Gyeongsangnam-do | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| ARKE Estudios Clínicos S.A. de C.V. Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Cuidados oncologicos Coordinator of this site? Confirm its status | Querétaro City | Mexico | Unknown status |
| Oncologico Potosino Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Auckland City Hospital, Cancer and Blood Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Waikato Hospital - Cancer and Blood Research Trials Unit Coordinator of this site? Confirm its status | Hamilton | New Zealand | Unknown status |
| Palmerston North Hospital Coordinator of this site? Confirm its status | Palmerston North | New Zealand | Unknown status |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Faculty of Med. Siriraj Hosp. Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Vajira Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chulalongkorn Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Songklanagarind Hospital Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Chang-hua | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tennessee Oncology - Chattanooga Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Inova Schar Cancer Institute Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| SCRI Florida Cancer Specialists South Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology, Inc Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Baptist Health Lexington Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Northwest Georgia Oncology Centers PC - Marietta Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Sarah Cannon Research Institute (Tennessee Oncology) Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| SCRI Florida Cancer Specialists North Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| PIH Health Whittier Hospital Coordinator of this site? Confirm its status | Whittier | United States | Unknown status |
| Advent Health Orlando Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
| Adana Baskent University Medical Faculty Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Ankara Bilkent City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Liv Hospital Ankara Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Dicle University Faculty of Medicine Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Unknown status |
| Trakya University Medical Faculty Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Medeniyet University Goztepe Training and Research Hospital. Coordinator of this site? Confirm its status | Kadiköy | Turkey (Türkiye) | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.