A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04256421 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: GO417672019-003301-97
• Study Type: interventional
• Target: 490
• Locations: 22 countries
• Sites: 118

Brief Summary

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).

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS)

  PFS was defined as the time from randomization to the first documented disease progression (PD) as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. PD: at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

  From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

• Overall Survival (OS) in the PAS

  OS was defined as the time from randomization to death from any cause.

  From randomization to death from any cause (up to approximately 24 months)

Secondary Outcomes (22)

• PFS in the FAS

  From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

• OS in the FAS

  From randomization to death from any cause (up to approximately 24 months)

• Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS

  From randomization up to approximately 24 months

• Investigator-Assessed Confirmed ORR in the FAS

  From randomization up to approximately 24 months

• Investigator-Assessed Duration of Response (DOR) in the PAS

  From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

Study Arms (2)

Placebo + Atezolizumab + CE

ACTIVE COMPARATOR

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.

Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide; Drug: Placebo

Tiragolumab + Atezolizumab + CE

EXPERIMENTAL

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.

Drug: Tiragolumab; Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide

Interventions

Atezolizumab DRUG

Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.

Also known as: Tecentriq

Placebo + Atezolizumab + CE; Tiragolumab + Atezolizumab + CE

Carboplatin DRUG

Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.

Placebo + Atezolizumab + CE; Tiragolumab + Atezolizumab + CE

Etoposide DRUG

Etoposide 100 mg/m\^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.

Placebo + Atezolizumab + CE; Tiragolumab + Atezolizumab + CE

Placebo DRUG

Placebo administered by IV infusion on Day 1 of each 21-day cycle.

Placebo + Atezolizumab + CE

Tiragolumab DRUG

Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.

Also known as: MTIG7192A

Tiragolumab + Atezolizumab + CE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Symptomatic or actively progressing central nervous system (CNS) metastases
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (121)

Rocky Mountain Cancer Centers - Lone Tree

Lone Tree, Colorado, 80124, United States

Location

MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

Washington D.C., District of Columbia, 20007, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

SCRI Florida Cancer Specialists North

Sarasota, Florida, 34232, United States

Location

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, 30060, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

New England Cancer Specialists

Scarborough, Maine, 04074, United States

Location

Weinberg Cancer Institution at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

Location

Broome Oncology - Binghamton

Binghamton, New York, 13905, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Sarah Cannon Research Institute / Tennessee Oncology

Chattanooga, Tennessee, 37404, United States

Location

Sarah Cannon Research Inst.

Nashville, Tennessee, 37203, United States

Location

Texas Oncology Cancer Center

Austin, Texas, 78731, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

Tiroler Landeskrankenanstalten Ges.M.B.H.

Innsbruck, 6020, Austria

Location

Klinik Penzing

Vienna, 1140, Austria

Location

Krankenhaus Nord - Klinik Floridsdorf

Vienna, 1210, Austria

Location

AZ St Maarten Campus Leopoldstr

Mechelen, 2800, Belgium

Location

Clinique Ste-Elisabeth

Namur, 5000, Belgium

Location

AZ Delta (Campus Rumbeke)

Roeselare, 8800, Belgium

Location

Vitaz

Sint-Niklaas, 9100, Belgium

Location

Oncocentro Serviços Médicos e Hospitalares Ltda

Fortaleza, Ceará, 60130-241, Brazil

Location

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Hospital de Clínicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Clínica de Oncologia Reichow

Blumenau, Santa Catarina, 89010-340, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Vitkovicka Nemocnice Bma, A.S.

Ostrava, 703 84, Czechia

Location

Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Location

Helios Klinikum Emil von Behring GmbH

Berlin, 14165, Germany

Location

LungenClinic Großhansdorf GmbH

Großhansdorf, 22927, Germany

Location

Asklepios Klinik Harburg

Hamburg, 21075, Germany

Location

Fachklinik für Lungenerkrankungen

Immenhausen, 34376, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Asklepios Klinik Gauting

München-Gauting, 82131, Germany

Location

General Hospital "G.Papanikolaou"

Asvestochóri, 570 10, Greece

Location

Uoa Sotiria Hospital

Athens, 115 27, Greece

Location

Metropolitan General Hospital

Cholargós, 155 62, Greece

Location

Univ General Hosp Heraklion

Heraklion, 711 10, Greece

Location

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, 1121, Hungary

Location

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

Szolnok, 5000, Hungary

Location

Tudogyogyintezet Torokbalint

Törökbálint, 2045, Hungary

Location

Irccs Ist. Tumori Giovanni Paolo Ii

Bari, Apulia, 70124, Italy

Location

AORN Ospedali dei Colli Ospedale Monaldi

Naples, Campania, 80131, Italy

Location

AUSL della Romagna

Ravenna, Emilia-Romagna, 48121, Italy

Location

IRCCS Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

Azienda Sanitaria Ospedaliera S Luigi Gonzaga

Orbassano, Piedmont, 10043, Italy

Location

Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico

Catania, Sicily, 95123, Italy

Location

IRCCS Istituto Oncologico Veneto (IOV)

Padua, Veneto, 35128, Italy

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Kindai University Hospital

Osaka, 589-8511, Japan

Location

NHO Kinki-Chuo Chest Medical Center

Osaka, 591-8555, Japan

Location

Saitama Cancer Center

Saitama, 362-0806, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Wakayama Medical University Hospital

Wakayama, 641-8510, Japan

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

Brzozów, 36-200, Poland

Location

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, 80-214, Poland

Location

Krakowski Szpital Specjalistyczny im sw.Jana Pawla II

Krakow, 31-202, Poland

Location

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, 10-357, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

Otwock, 05-400, Poland

Location

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, 60-569, Poland

Location

Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

Warsaw, 02-781, Poland

Location

Principal Military Clinical Hospital n.a. N.N. Burdenko

Moscow, Moscow Oblast, 105229, Russia

Location

Blokhin Cancer Research Center

Moscow, Moscow Oblast, Russia

Location

Scientific Research Institute n.a. N.N. Petrov

Saint Petersburg, Sankt-Peterburg, 187758, Russia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Hospital Center ''Bezanijska Kosa''

Belgrade, 11080, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

National University Hospital

Singapore, 119228, Singapore

Location

National Cancer Centre

Singapore, 168583, Singapore

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Samsung Changwon Hospital

Gyeongsangnam-do, 51353, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St Mary's Hospital

Seoul, 06591, South Korea

Location

Ulsan University Hosiptal

Ulsan, 44033, South Korea

Location

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

CHUV

Lausanne, 1011, Switzerland

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

National Cheng-Kung University Hospital

Tainan, 70401, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang-Gung Medical Foundation, Linkou Branch

Taoyuan District, 333, Taiwan

Location

National Taiwan University Hospital

Zhongzheng Dist., 10048, Taiwan

Location

Adana Baskent University Hospital

Adana, 01120, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

Location

Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

?zmir Medical Park

Izm?r, 35575, Turkey (Türkiye)

Location

NHS Lothian - Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Guys and St Thomas Hospital

London, SE1 9RT, United Kingdom

Location

Christie Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37976444 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Tiragolumab; atezolizumab; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: February 4, 2020
• Primary Completion: September 6, 2022
• Study Completion: July 31, 2025
• Last Updated: January 28, 2026
• Results First Posted: October 22, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (4); NZ (1); GB (4); US (18); KR (10); ES (8); AU (4); RU (3); GR (4); JP (11); CZ (3); CH (2); TU (6); PL (7); SE (3); DE (6); BR (6); HU (3); IT (7); NL (2); SG (2); TW (4)