NCT04256421CompletedPhase 3
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (</= upper limit of normal [ULN] vs. > ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 490 (actual)
- First submitted
- 31 Jan 2020
- Start date
- 4 Feb 2020
- Primary completion date
- 6 Sept 2022
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Lung cancer
- NCT number
- NCT04256421
- EU CT number
- 2022-502988-37-00
- EudraCT number
- 2019-003301-97
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 490
- From 4 Feb 2020 to the primary completion date, 6 Sept 2022
- 112 sites in 23 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Treatment with any other investigational agent within 28 days prior to initiation of study treatment
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization
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 on screening chest computed tomography (CT) scan
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Severe infection at the time of randomization
Lab values
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Other
- Symptomatic or actively progressing central nervous system (CNS) metastases
Who the study is looking for
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
- No prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Adequate hematologic and end-organ function
- Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (112)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tiroler Landeskrankenanstalten Ges.M.B.H. Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Klinik Penzing Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Krankenhaus Nord - Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Sunshine Coast University Hospital Coordinator of this site? Confirm its status | Birtinya | Australia | Unknown status |
| Chris O'Brien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Lyell McEwin Hospital Coordinator of this site? Confirm its status | Elizabeth Vale | Australia | Unknown status |
| Nepean Hospital Coordinator of this site? Confirm its status | Kingswood | Australia | Unknown status |
| AZ St Maarten Campus Leopoldstr Coordinator of this site? Confirm its status | Mechelen | Belgium | Unknown status |
| Clinique Ste-Elisabeth Coordinator of this site? Confirm its status | Namur | Belgium | Unknown status |
| AZ Delta (Campus Rumbeke) Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Unknown status |
| Clínica de Oncologia Reichow Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| Oncocentro Serviços Médicos e Hospitalares Ltda Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Hospital de Clinicas de Passo Fundo Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Unknown status |
| Hospital Nossa Senhora da Conceição Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Rafael - HSR Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Instituto do Cancer do Estado de Sao Paulo - ICESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CHUV Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Vitkovicka Nemocnice Bma, A.S. Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Thomayerova nemocnice Coordinator of this site? Confirm its status | Praha 4 - Krc | Czechia | Unknown status |
| Helios Klinikum Emil von Behring GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| LungenClinic Großhansdorf GmbH Coordinator of this site? Confirm its status | Großhansdorf | Germany | Unknown status |
| Asklepios Klinik Harburg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Fachklinik für Lungenerkrankungen Coordinator of this site? Confirm its status | Immenhausen | Germany | Unknown status |
| Universitätsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Asklepios Klinik Gauting Coordinator of this site? Confirm its status | München-Gauting | Germany | Unknown status |
| Hospital Clinic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clinico Universitario Virgen de La Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| NHS Lothian - Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Guys and St Thomas Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Christie Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Royal Cornwall Hospital Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. Coordinator of this site? Confirm its status | Cholargos | Greece | Completed |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Orszagos Koranyi Tbc es Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int. Coordinator of this site? Confirm its status | Szolnok | Hungary | Unknown status |
| Tudogyogyintezet Torokbalint Coordinator of this site? Confirm its status | Törökbálint | Hungary | Unknown status |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| NHO Kinki-Chuo Chest Medical Center 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 |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| National Cancer Center Hospital 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 |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| National Cancer Center 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 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 |
| Samsung Medical Center 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 |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hosiptal Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Coordinator of this site? Confirm its status | Otwock | Poland | Completed |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Clinical Center of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical hospital center Bezanijska Kosa Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Institute for Pulmonary Diseases of Vojvodina Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
| Principal Military Clinical Hospital n.a. N.N. Burdenko Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Blokhin Cancer Research Center Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Scientific Research Institute n.a. N.N. Petrov Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National Cancer Centre Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Adana Baskent University Hospital Coordinator of this site? Confirm its status | Adana | Türkiye | Unknown status |
| Ankara University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Türkiye | Unknown status |
| Gazi University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Türkiye | Unknown status |
| Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Türkiye | Unknown status |
| Medipol University Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Türkiye | Unknown status |
| ?zmir Medical Park Coordinator of this site? Confirm its status | Izm?r | Türkiye | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Zhongzheng Dist. | Taiwan | Unknown status |
| Texas Oncology Cancer Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Weinberg Cancer Institution at Franklin Square Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Broome Oncology - Binghamton Coordinator of this site? Confirm its status | Binghamton | United States | Unknown status |
| Sarah Cannon Research Institute / Tennessee Oncology Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Rocky Mountain Cancer Centers - Lone Tree Coordinator of this site? Confirm its status | Lone Tree | United States | Unknown status |
| University of Wisconsin School of Medicine and Public Health Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Northwest Georgia Oncology Centers PC - Marietta Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Minnesota Oncology Hematology Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Sarah Cannon Research Inst. Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Illinois Cancer Care Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Blue Ridge Cancer Care Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| SCRI Florida Cancer Specialists North Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| New England Cancer Specialists Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.