Lung Cancer Clinical Trial

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

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 ( 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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

490

Study ID:

NCT04256421

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 121 Locations for this study

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Rocky Mountain Cancer Centers - Lone Tree
Lone Tree Colorado, 80124, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington District of Columbia, 20007, United States
Florida Cancer Specialists; SCRI; Florida Cancer Specialists - Sarasota (Golf St)
Fort Myers Florida, 33901, United States
SCRI Florida Cancer Specialists North; Research Office North Region.
Saint Petersburg Florida, 33705, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Weinberg Cancer Institution at Franklin Square
Baltimore Maryland, 21237, United States
Minnesota Oncology Hematology
Saint Paul Minnesota, 55102, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
Broome Oncology - Binghamton
Binghamton New York, 13905, United States
Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Texas Oncology Cancer Center
Austin Texas, 78731, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Blue Ridge Cancer Care
Roanoke Virginia, 24014, United States
University of Wisconsin School of Medicine and Public Health
Madison Wisconsin, 53792, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Nepean Hospital; Nepean Cancer Care Centre
Kingswood New South Wales, 2747, Australia
Sunshine Coast University Hospital; The Adem Crosby Centre
Birtinya Queensland, 4575, Australia
Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit
Elizabeth Vale South Australia, 5112, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck , 6020, Austria
SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung
Wien , 1140, Austria
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
Wien , 1210, Austria
AZ St Maarten Campus Leopoldstr
Mechelen , 2800, Belgium
Clinique Ste-Elisabeth
Namur , 5000, Belgium
AZ Delta (Campus Rumbeke)
Roeselare , 8800, Belgium
Vitaz
Sint Niklaas , 9100, Belgium
Hospital Sao Rafael - HSR
Salvador BA, 41253, Brazil
Oncocentro Serviços Médicos e Hospitalares Ltda
Fortaleza CE, 60130, Brazil
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
Passo Fundo RS, 99010, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 91350, Brazil
Clínica de Oncologia Reichow
Blumenau SC, 89010, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Fakultni nemocnice Olomouc; Pneumologicka klinika
Olomouc , 775 2, Czechia
Vitkovicka Nemocnice Bma, A.S.; Plicni Oddeleni
Ostrava , 703 8, Czechia
Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN
Praha 4 - Krc , 140 5, Czechia
Helios Klinikum Emil von Behring GmbH
Berlin , 14165, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf , 22927, Germany
Asklepios Klinik Harburg
Hamburg , 21075, Germany
Fachklinik für Lungenerkrankungen
Immenhausen , 34376, Germany
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Lübeck , 23538, Germany
Asklepios Klinik München-Gauting
München-Gauting , 82131, Germany
General Hospital "G.Papanikolaou"; Pulmonogy Clinic
Asvestochori , 570 1, Greece
Uoa Sotiria Hospital; Oncology
Athens , 115 2, Greece
Metropolitan General Hospital
Cholargos , 155 6, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion , 711 1, Greece
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest , 1121, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok , 5000, Hungary
Tudogyogyintezet Torokbalint
Torokbalint , 2045, Hungary
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
Napoli Campania, 80131, Italy
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
Ravenna Emilia-Romagna, 48121, Italy
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano Lombardia, 20089, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano Piemonte, 10043, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari Puglia, 70124, Italy
Azienda Ospedaliero-Universitaria "PoliclinicoVittorio Emanuele"- P.O. G. Rodolico; Oncologia Medica
Catania Sicilia, 95123, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena Toscana, 53100, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padova Veneto, 35128, Italy
National Cancer Center Hospital East
Chiba , 277-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Kindai University Hospital
Osaka , 589-8, Japan
Saitama Cancer Center
Saitama , 362-0, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi , 591-8, Japan
Shizuoka Cancer Center
Shizuoka , 411-8, Japan
National Cancer Center Hospital
Tokyo , 104-0, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Samsung Changwon Hospital
Gyeongsangnam-do , 51353, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Seoul St Mary's Hospital
Seoul , 06591, Korea, Republic of
Ulsan University Hosiptal
Ulsan , 44033, Korea, Republic of
Maastricht University Medical Center
Maastricht , 6229 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands
Auckland City Hospital; Clinical Oncology
Auckland , 1023, New Zealand
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów , 36-20, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk , 80-21, Poland
Krakowski Szpital Specjalistyczny im.Jana Pawla II
Krakow , 31-20, Poland
Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn , 10-35, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock , 05-40, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan , 60-56, Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
Warszawa , 02-78, Poland
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow Moskovskaja Oblast, 10522, Russian Federation
BLOKHIN CANCER RESEARCH CENTER; CLINICAL ONCOLOGY; Clinical pharmacology and chemotheraphy
Moscow , , Russian Federation
Scientific Research Institute n.a. N.N. Petrov
Saint Petersburg , 19775, Russian Federation
Clinical Center of Serbia; Clinic for Pulmonary Diseases
Belgrade , 11000, Serbia
Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
Belgrade , 11080, Serbia
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica , 21204, Serbia
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore , 11922, Singapore
National Cancer Centre; Medical Oncology
Singapore , 16961, Singapore
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona , 08035, Spain
Hospital Clinic Barcelona; Servicio de oncologia
Barcelona , 08036, Spain
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia , 46010, Spain
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
Zaragoza , 50009, Spain
CHUV; Departement d'Oncologie
Lausanne , 1011, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich , 8091, Switzerland
National Cheng-Kung University Hospital
Tainan , , Taiwan
Taipei Veterans General Hospital
Taipei City , 11217, Taiwan
Chang-Gung Medical Foundation, Linkou Branch
Taoyuan , 333, Taiwan
National Taiwan University Hospital; Oncology
Zhongzheng Dist. , 10048, Taiwan
Adana Baskent University Hospital; Medical Oncology
Adana , 01120, Turkey
Ankara University Medical Faculty; Medikal Onkoloji
Ankara , 06100, Turkey
Gazi University Medical Faculty
Ankara , 06500, Turkey
Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani
Istanbul , 34098, Turkey
Medipol University MF; Oncology Department
Istanbul , 34214, Turkey
İzmir Medical Park; Onkoloji
Izmır , 35575, Turkey
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
Edinburgh , EH4 2, United Kingdom
Guys and St Thomas Hospital
London , SE1 9, United Kingdom
Christie Foundation Trust
Manchester , M20 4, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton , SM2 5, United Kingdom
Royal Cornwall Hospital
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

490

Study ID:

NCT04256421

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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