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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

Full criteria on ClinicalTrials.gov

Sites (112)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Tiroler Landeskrankenanstalten Ges.M.B.H.
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InnsbruckAustriaUnknown status
Klinik Penzing
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ViennaAustriaUnknown status
Krankenhaus Nord - Klinik Floridsdorf
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ViennaAustriaUnknown status
Sunshine Coast University Hospital
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BirtinyaAustraliaUnknown status
Chris O'Brien Lifehouse
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CamperdownAustraliaUnknown status
Lyell McEwin Hospital
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Elizabeth ValeAustraliaUnknown status
Nepean Hospital
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KingswoodAustraliaUnknown status
AZ St Maarten Campus Leopoldstr
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MechelenBelgiumUnknown status
Clinique Ste-Elisabeth
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NamurBelgiumUnknown status
AZ Delta (Campus Rumbeke)
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RoeselareBelgiumUnknown status
Vitaz
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Sint-NiklaasBelgiumUnknown status
Clínica de Oncologia Reichow
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BlumenauBrazilUnknown status
Oncocentro Serviços Médicos e Hospitalares Ltda
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FortalezaBrazilUnknown status
Hospital de Clinicas de Passo Fundo
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Passo FundoBrazilUnknown status
Hospital Nossa Senhora da Conceição
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Porto AlegreBrazilUnknown status
Hospital Sao Rafael - HSR
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SalvadorBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
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São PauloBrazilUnknown status
CHUV
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LausanneSwitzerlandUnknown status
Universitätsspital Zürich
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ZurichSwitzerlandUnknown status
Fakultni nemocnice Olomouc
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OlomoucCzechiaUnknown status
Vitkovicka Nemocnice Bma, A.S.
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OstravaCzechiaUnknown status
Thomayerova nemocnice
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Praha 4 - KrcCzechiaUnknown status
Helios Klinikum Emil von Behring GmbH
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BerlinGermanyUnknown status
LungenClinic Großhansdorf GmbH
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GroßhansdorfGermanyUnknown status
Asklepios Klinik Harburg
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HamburgGermanyUnknown status
Fachklinik für Lungenerkrankungen
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ImmenhausenGermanyUnknown status
Universitätsklinikum Schleswig-Holstein
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LübeckGermanyUnknown status
Asklepios Klinik Gauting
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München-GautingGermanyUnknown status
Hospital Clinic Barcelona
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BarcelonaSpainUnknown status
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
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BarcelonaSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Clinico Universitario Virgen de La Victoria
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MálagaSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status
NHS Lothian - Western General Hospital
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EdinburghUnited KingdomUnknown status
Guys and St Thomas Hospital
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LondonUnited KingdomUnknown status
Christie Foundation Trust
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ManchesterUnited KingdomUnknown status
Royal Cornwall Hospital
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TruroUnited KingdomUnknown status
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
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CholargosGreeceCompleted
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceCompleted
Orszagos Koranyi Tbc es Pulmonologiai Intezet
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BudapestHungaryUnknown status
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
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SzolnokHungaryUnknown status
Tudogyogyintezet Torokbalint
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TörökbálintHungaryUnknown status
Azienda Ospedaliera dei Colli
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NaplesItalyCompleted
Istituto Oncologico Veneto
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PadovaItalyCompleted
National Cancer Center Hospital East
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ChibaJapanUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Osaka International Cancer Institute
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OsakaJapanUnknown status
NHO Kinki-Chuo Chest Medical Center
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OsakaJapanUnknown status
Kindai University Hospital
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OsakaJapanUnknown status
Saitama Cancer Center
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SaitamaJapanUnknown status
Shizuoka Cancer Center
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ShizuokaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
National Cancer Center Hospital
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TokyoJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Gyeonggi-doSouth KoreaUnknown status
National Cancer Center
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Gyeonggi-doSouth KoreaUnknown status
Samsung Changwon Hospital
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Gyeongsangnam-doSouth KoreaUnknown status
Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Ulsan University Hosiptal
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UlsanSouth KoreaUnknown status
Maastricht University Medical Center
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MaastrichtNetherlandsUnknown status
Erasmus MC
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RotterdamNetherlandsUnknown status
Auckland City Hospital
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AucklandNew ZealandUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandCompleted
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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OtwockPolandCompleted
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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PoznanPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Clinical Center of Serbia
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BelgradeSerbiaUnknown status
Clinical hospital center Bezanijska Kosa
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BelgradeSerbiaUnknown status
Institute for Pulmonary Diseases of Vojvodina
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KamenitzSerbiaUnknown status
Principal Military Clinical Hospital n.a. N.N. Burdenko
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MoscowRussiaUnknown status
Blokhin Cancer Research Center
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MoscowRussiaUnknown status
Scientific Research Institute n.a. N.N. Petrov
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Saint PetersburgRussiaUnknown status
National University Hospital
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SingaporeSingaporeUnknown status
National Cancer Centre
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SingaporeSingaporeUnknown status
Adana Baskent University Hospital
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AdanaTürkiyeUnknown status
Ankara University Medical Faculty
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AnkaraTürkiyeUnknown status
Gazi University Medical Faculty
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AnkaraTürkiyeUnknown status
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty
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IstanbulTürkiyeUnknown status
Medipol University Medical Faculty
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IstanbulTürkiyeUnknown status
?zmir Medical Park
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Izm?rTürkiyeUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanUnknown status
National Taiwan University Hospital
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Zhongzheng Dist.TaiwanUnknown status
Texas Oncology Cancer Center
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AustinUnited StatesUnknown status
Weinberg Cancer Institution at Franklin Square
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BaltimoreUnited StatesUnknown status
Broome Oncology - Binghamton
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BinghamtonUnited StatesUnknown status
Sarah Cannon Research Institute / Tennessee Oncology
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ChattanoogaUnited StatesUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
Florida Cancer Specialists
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Fort MyersUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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HendersonUnited StatesUnknown status
Rocky Mountain Cancer Centers - Lone Tree
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Lone TreeUnited StatesUnknown status
University of Wisconsin School of Medicine and Public Health
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MadisonUnited StatesUnknown status
Northwest Georgia Oncology Centers PC - Marietta
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MariettaUnited StatesUnknown status
Minnesota Oncology Hematology
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MinneapolisUnited StatesUnknown status
Sarah Cannon Research Inst.
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NashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Illinois Cancer Care
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PeoriaUnited StatesUnknown status
Blue Ridge Cancer Care
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RoanokeUnited StatesUnknown status
SCRI Florida Cancer Specialists North
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SarasotaUnited StatesUnknown status
New England Cancer Specialists
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ScarboroughUnited StatesUnknown status
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.