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 (= 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).
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
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There are 120 Locations for this study
Lone Tree Colorado, 80124, United States
Washington District of Columbia, 20007, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
Marietta Georgia, 30060, United States
Peoria Illinois, 61615, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21237, United States
Saint Paul Minnesota, 55102, United States
Las Vegas Nevada, 89128, United States
Binghamton New York, 13905, United States
New York New York, 10029, United States
New York New York, 11101, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78731, United States
Fairfax Virginia, 22031, United States
Roanoke Virginia, 24014, United States
Madison Wisconsin, 53792, United States
Camperdown New South Wales, 2050, Australia
Kingswood New South Wales, 2747, Australia
Birtinya Queensland, 4575, Australia
Elizabeth Vale South Australia, 5112, Australia
Innsbruck , 6020, Austria
Wien , 1140, Austria
Wien , 1210, Austria
Mechelen , 2800, Belgium
Namur , 5000, Belgium
Roeselare , 8800, Belgium
Sint Niklaas , 9100, Belgium
Salvador BA, 41253, Brazil
Fortaleza CE, 60130, Brazil
Passo Fundo RS, 99010, Brazil
Porto Alegre RS, 91350, Brazil
Blumenau SC, 89010, Brazil
Sao Paulo SP, 01246, Brazil
Olomouc , 779 0, Czechia
Ostrava , 703 8, Czechia
Praha 4 - Krc , 140 5, Czechia
Berlin , 14165, Germany
Großhansdorf , 22927, Germany
Hamburg , 21075, Germany
Immenhausen , 34376, Germany
Lübeck , 23538, Germany
München-Gauting , 82131, Germany
Asvestochori , 570 1, Greece
Athens , 115 2, Greece
Cholargos , 155 6, Greece
Heraklion , 711 1, Greece
Budapest , 1121, Hungary
Szolnok , 5000, Hungary
Torokbalint , 2045, Hungary
Napoli Campania, 80131, Italy
Ravenna Emilia-Romagna, 48121, Italy
Rozzano Lombardia, 20089, Italy
Orbassano Piemonte, 10043, Italy
Bari Puglia, 70124, Italy
Catania Sicilia, 95123, Italy
Siena Toscana, 53100, Italy
Padova Veneto, 35128, Italy
Chiba , 277-8, Japan
Fukuoka , 812-8, Japan
Niigata , 951-8, Japan
Osaka , 541-8, Japan
Osaka , 589-8, Japan
Saitama , 362-0, Japan
Sakai-shi , 591-8, Japan
Shizuoka , 411-8, Japan
Tokyo , 104-0, Japan
Tokyo , 135-8, Japan
Wakayama , 641-8, Japan
Cheongju-si , 28644, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Gyeongsangnam-do , 51353, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Maastricht , 6229 , Netherlands
Rotterdam , 3015 , Netherlands
Auckland , 1023, New Zealand
Brzozów , 36-20, Poland
Gdansk , 80-21, Poland
Krakow , 31-20, Poland
Olsztyn , 10-35, Poland
Otwock , 05-40, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Moscow Moskovskaja Oblast, 10522, Russian Federation
Moscow , , Russian Federation
Saint Petersburg , 19775, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11080, Serbia
Sremska Kamenica , 21204, Serbia
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Zaragoza , 50009, Spain
Lausanne , 1011, Switzerland
Zürich , 8091, Switzerland
Tainan , , Taiwan
Taipei City , 11217, Taiwan
Taoyuan , 333, Taiwan
Zhongzheng Dist. , 10048, Taiwan
Adana , 01120, Turkey
Ankara , 06100, Turkey
Ankara , 06500, Turkey
Istanbul , 34098, Turkey
Istanbul , 34214, Turkey
Izmir , , Turkey
Edinburgh , EH4 2, United Kingdom
London , SE1 9, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
Truro , TR1 3, United Kingdom
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