Lung Cancer Clinical Trial
A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
Summary
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
No prior systemic treatment for metastatic NSCLC
High tumor tissue PD-L1 expression
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Adequate hematologic and end-organ function
For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.
Exclusion Criteria:
Known mutation in the EGFR gene or an ALK fusion oncogene
Symptomatic, untreated, or actively progressing central nervous system metastases
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
Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Severe infection within 4 weeks prior to initiation of study treatment
Positive test result for human immunodeficiency virus (HIV)
Active hepatitis B or hepatitis C
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, 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 initiation of study treatment.
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There are 171 Locations for this study
Littleton Colorado, 80120, United States
New Haven Connecticut, 06520, United States
Saint Petersburg Florida, 33705, United States
Tallahassee Florida, 32308, United States
Arlington Heights Illinois, 60005, United States
Detroit Michigan, 48201, United States
Saint Paul Minnesota, 55102, United States
Cincinnati Ohio, 45242, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78731, United States
Fairfax Virginia, 22031, United States
Salem Virginia, 24153, United States
Vancouver Washington, 98684, United States
Buenos Aires , C1125, Argentina
Capital Federal , 1426, Argentina
Vicente López , B1602, Argentina
Viedma Rio Negro , R8500, Argentina
Darlinghurst New South Wales, 2010, Australia
Woolloongabba Queensland, 4102, Australia
Frankston Victoria, 3199, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Linz , 4020, Austria
Wels , 4600, Austria
Wien , 1140, Austria
Wien , 1210, Austria
Ijui RS, 98700, Brazil
Porto Alegre RS, 90610, Brazil
Barretos SP, 14784, Brazil
Beijing , 10014, China
Beijing , 10114, China
Changchun City , 13002, China
Changzhou , 21300, China
Chengdu , 61004, China
Fuzhou , 35001, China
Guangzhou , 51000, China
Haikou , 57031, China
Hangzhou City , 31001, China
Harbin , 15008, China
Jinan City , 25001, China
Meizhou City , 51403, China
Nanchang , 33001, China
Nantong City , 22636, China
Shanghai City , 20012, China
Shanghai , 20003, China
Shanghai , 20043, China
Tianjin , 30006, China
Wuhan City , 43002, China
Xi'an , 71006, China
Xiamen , 36100, China
Zhejiang , 31002, China
Zhengzhou , 45000, China
Aalborg , 9000, Denmark
København Ø , 2100, Denmark
Roskilde , 4000, Denmark
Bordeaux , 33076, France
Creteil , 94010, France
Dijon , 21079, France
Nantes , 44093, France
Saint Quentin , 2100, France
Strasbourg , 67065, France
Toulouse , 31059, France
Frankfurt , 60488, Germany
Großhansdorf , 22927, Germany
Halle (Saale) , 06120, Germany
Immenhausen , 34376, Germany
Löwenstein , 74245, Germany
Münster , 48153, Germany
Stuttgart , 70376, Germany
Athens , 104 3, Greece
Athens , 185 4, Greece
Heraklion , 711 1, Greece
Larissa , 411 1, Greece
Thessaloniki , 570 0, Greece
Budapest , 1121, Hungary
Farkasgyepu , 8582, Hungary
Matrahaza , 3233, Hungary
Szolnok , 5004, Hungary
Avellino Campania, 83100, Italy
Napoli Campania, 80131, Italy
Parma Emilia-Romagna, 43100, Italy
Roma Lazio, 00168, Italy
Roma Lazio, 151, Italy
Milano Lombardia, 20141, Italy
Monza Lombardia, 20900, Italy
Rozzano Lombardia, 20089, Italy
Orbassano Piemonte, 10043, Italy
Sant'Andrea Delle Fratte (PG) Umbria, 06132, Italy
Padova Veneto, 35128, Italy
Aichi , 464-8, Japan
Chiba , 277-8, Japan
Fukuoka , 812-8, Japan
Miyagi , 980-0, Japan
Niigata , 951-8, Japan
Okayama , 700-8, 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
Cheongju-si , 28644, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Gyeonggi-do , 16499, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seongnam-si , 463-7, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 08308, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Suwon , 442-7, Korea, Republic of
Cdmx Mexico CITY (federal District), 03100, Mexico
Mexico Mexico CITY (federal District), 06100, Mexico
Querétaro Queretaro, 76000, Mexico
Monterrey , 64710, Mexico
'S Hertogenbosch , 5223 , Netherlands
Den-Haag , 2545 , Netherlands
EDE , 6716 , Netherlands
Leeuwarden , 8934 , Netherlands
Arequipa , 5154, Peru
Lima , Lima , Peru
Lima , Lima , Peru
San Isidro , Lima , Peru
Gda?sk , 80-21, Poland
Olsztyn , 10-35, Poland
Otwock , 05-40, Poland
Poznan , 60-56, Poland
Moscow Moskovskaja Oblast, 10522, Russian Federation
Moscow Moskovskaja Oblast, 14342, Russian Federation
Novosibirsk , 63004, Russian Federation
St Petersburg , 18964, Russian Federation
St Petersburg , 19429, Russian Federation
St Petersburg , 19708, Russian Federation
ST Petersburg , 19775, Russian Federation
Yaroslavl , 15004, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11080, Serbia
Sremska Kamenica , 21204, Serbia
Badalona Barcelona, 08916, Spain
Majadahonda Madrid, 28220, Spain
Alicante , 03010, Spain
Barcelona , 08035, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Sevilla , 41013, Spain
Zaragoza , 50009, Spain
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Lausanne , 1011, Switzerland
St. Gallen , 9000, Switzerland
Kaohsiung City , 807, Taiwan
Kaohsiung , 83301, Taiwan
New Taipei City , 23561, Taiwan
Taichung , 407, Taiwan
Tainan , 704, Taiwan
Taipei , 112, Taiwan
Taipei , , Taiwan
Zhongzheng Dist. , 10048, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Songkhla , 90110, Thailand
Adana , 01120, Turkey
Ankara , 06100, Turkey
Istanbul , 34098, Turkey
Izmir , 35110, Turkey
Kadiköy , 34722, Turkey
Malatya , 44280, Turkey
Dnipropetrovsk , 49102, Ukraine
Ivano-Frankivsk , 76018, Ukraine
Kryvyi Rih , 50048, Ukraine
Sumy , 40005, Ukraine
Uzhgorod , 88000, Ukraine
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