A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT04256421
Last Updated: 2025-10-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
490 participants
INTERVENTIONAL
2020-02-04
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
NCT02763579
A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
NCT04832854
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
NCT04513925
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
NCT04619797
A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy
NCT06267001
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo + Atezolizumab + CE
Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
Atezolizumab
Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Etoposide
Etoposide 100 mg/m\^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
Placebo
Placebo administered by IV infusion on Day 1 of each 21-day cycle.
Tiragolumab + Atezolizumab + CE
Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
Tiragolumab
Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Etoposide
Etoposide 100 mg/m\^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tiragolumab
Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Etoposide
Etoposide 100 mg/m\^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
Placebo
Placebo administered by IV infusion on Day 1 of each 21-day cycle.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
* Treatment with any other investigational agent within 28 days prior to initiation of study treatment
* 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
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rocky Mountain Cancer Centers - Lone Tree
Lone Tree, Colorado, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
SCRI Florida Cancer Specialists North
Sarasota, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
Illinois Cancer Care
Peoria, Illinois, United States
New England Cancer Specialists
Scarborough, Maine, United States
Weinberg Cancer Institution at Franklin Square
Baltimore, Maryland, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Broome Oncology - Binghamton
Binghamton, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, United States
Sarah Cannon Research Inst.
Nashville, Tennessee, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.
Innsbruck, , Austria
Klinik Penzing
Vienna, , Austria
Krankenhaus Nord - Klinik Floridsdorf
Vienna, , Austria
AZ St Maarten Campus Leopoldstr
Mechelen, , Belgium
Clinique Ste-Elisabeth
Namur, , Belgium
AZ Delta (Campus Rumbeke)
Roeselare, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Oncocentro Serviços Médicos e Hospitalares Ltda
Fortaleza, Ceará, Brazil
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital de Clínicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Clínica de Oncologia Reichow
Blumenau, Santa Catarina, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Vitkovicka Nemocnice Bma, A.S.
Ostrava, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Helios Klinikum Emil von Behring GmbH
Berlin, , Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, , Germany
Asklepios Klinik Harburg
Hamburg, , Germany
Fachklinik für Lungenerkrankungen
Immenhausen, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Asklepios Klinik Gauting
München-Gauting, , Germany
General Hospital "G.Papanikolaou"
Asvestochóri, , Greece
Uoa Sotiria Hospital
Athens, , Greece
Metropolitan General Hospital
Cholargós, , Greece
Univ General Hosp Heraklion
Heraklion, , Greece
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok, , Hungary
Tudogyogyintezet Torokbalint
Törökbálint, , Hungary
Irccs Ist. Tumori Giovanni Paolo Ii
Bari, Apulia, Italy
AORN Ospedali dei Colli Ospedale Monaldi
Napoli, Campania, Italy
AUSL della Romagna
Ravenna, Emilia-Romagna, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piedmont, Italy
Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico
Catania, Sicily, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padua, Veneto, Italy
National Cancer Center Hospital East
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
NHO Kinki-Chuo Chest Medical Center
Osaka, , Japan
Saitama Cancer Center
Saitama, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
National Cancer Center Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Maastricht University Medical Center
Maastricht, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
Brzozów, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, , Poland
Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
Krakow, , Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Otwock, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, , Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
Warsaw, , Poland
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Moscow Oblast, Russia
Blokhin Cancer Research Center
Moscow, Moscow Oblast, Russia
Scientific Research Institute n.a. N.N. Petrov
Saint Petersburg, Sankt-Peterburg, Russia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Center ''Bezanijska Kosa''
Belgrade, , Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, , Serbia
National University Hospital
Singapore, , Singapore
National Cancer Centre
Singapore, , Singapore
Chungbuk National University Hospital
Cheongju-si, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Samsung Changwon Hospital
Gyeongsangnam-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
CHUV
Lausanne, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
National Cheng-Kung University Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang-Gung Medical Foundation, Linkou Branch
Taoyuan District, , Taiwan
National Taiwan University Hospital
Zhongzheng Dist., , Taiwan
Adana Baskent University Hospital
Adana, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty
Istanbul, , Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, , Turkey (Türkiye)
?zmir Medical Park
Izm?r, , Turkey (Türkiye)
NHS Lothian - Western General Hospital
Edinburgh, , United Kingdom
Guys and St Thomas Hospital
London, , United Kingdom
Christie Foundation Trust
Manchester, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rudin CM, Liu SV, Soo RA, Lu S, Hong MH, Lee JS, Bryl M, Dumoulin DW, Rittmeyer A, Chiu CH, Ozyilkan O, Johnson M, Navarro A, Novello S, Ozawa Y, Tam SH, Patil NS, Wen X, Huang M, Hoang T, Meng R, Reck M. SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2024 Jan 20;42(3):324-335. doi: 10.1200/JCO.23.01363. Epub 2023 Nov 17.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-003301-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO41767
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.