Lung Cancer Clinical Trial
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
Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).
Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase:
Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin
Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin
Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
No prior systemic treatment for metastatic non-squamous NSCLC
Known tumor programmed death-ligand 1 (PD-L1) status
Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Life expectancy >= 12 weeks
Adequate hematologic and end-organ function
Negative human immunodeficiency virus (HIV) test at screening
Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.
Key Exclusion Criteria:
Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
Symptomatic, untreated, or actively progressing central nervous system (CNS) 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
History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death
Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 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 (whichever is longer) prior to initiation of study treatment
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
Women who are pregnant, or breastfeeding
Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.
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There are 170 Locations for this study
Jonesboro Arkansas, 72401, United States
Little Rock Arkansas, 72205, United States
Los Angeles California, 90095, United States
Oakland California, 94611, United States
Roseville California, 95661, United States
Sacramento California, 95814, United States
San Francisco California, 94115, United States
San Jose California, 95119, United States
San Leandro California, 94577, United States
Santa Clara California, 95051, United States
South San Francisco California, 94080, United States
Torrance California, 90505, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Whittier California, 90602, United States
Fort Myers Florida, 33916, United States
Orlando Florida, 32804, United States
Orlando Florida, 32806, United States
Saint Petersburg Florida, 33705, United States
Marietta Georgia, 30060, United States
Fort Wayne Indiana, 46804, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40503, United States
Boston Massachusetts, 02118, United States
Reno Nevada, 89511, United States
New York New York, 10065, United States
Chattanooga Tennessee, 37404, United States
Kingsport Tennessee, 37660, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37203, United States
Bristol Virginia, 24201, United States
Fairfax Virginia, 22031, United States
Midlothian Virginia, 23114, United States
Spokane Washington, 99208, United States
Aalst , 9300, Belgium
Bruxelles , 1200, Belgium
Hasselt , 3500, Belgium
Liège , 4000, Belgium
Mont-godinne , 5530, Belgium
Sint Niklaas , 9100, Belgium
Fortaleza CE, 60336, Brazil
Belo Horizonte MG, 30360, Brazil
Ijui RS, 98700, Brazil
Porto Alegre RS, 90035, Brazil
Porto Alegre RS, 91350, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Edmonton Alberta, T6G 1, Canada
Barrie Ontario, L4M 6, Canada
London Ontario, N6A 4, Canada
Oshawa Ontario, L1G 2, Canada
Sault Ste. Marie Ontario, P6B 0, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H1T 2, Canada
Beijing , 10014, China
Changchun , 13201, China
Changsha City , 41000, China
Changzhou , 21300, China
Chengde City , 06702, China
Chengdu City , 61004, China
Chengdu City , 61004, China
Dongguan , 51170, China
Guangzhou , 51000, China
Hangzhou City , 31001, China
Hefei , 23008, China
Jinan City , 25001, China
Liaocheng , 05490, China
Linyi City , 27603, China
Luoyang , 47100, China
Pingxiang City , 33700, China
Qingdao City , 26604, China
Weifang City , 26104, China
Wuhan , 43007, China
Xi'an City , 71006, China
Xinxiang City , 45300, China
Yangzhou City , 22500, China
Zhengzhou , 45005, China
København Ø , 2100, Denmark
Odense C , 5000, Denmark
Roskilde , 4000, Denmark
Bordeaux , 33076, France
Marseille cedex 20 , 13915, France
Paris , 75231, France
Rennes , 35033, France
Strasbourg , 67091, France
Toulouse cedex 9 , 31100, France
Berlin , 14165, Germany
Bochum , 44791, Germany
Chemnitz , 09116, Germany
Karlsruhe , 76137, Germany
Mainz , 55131, Germany
Marburg , 35032, Germany
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Shatin , , Hong Kong
Bologna Emilia-Romagna, 40138, Italy
Aviano Friuli-Venezia Giulia, 33081, Italy
Genova Liguria, 16149, Italy
Bergamo Lombardia, 24127, Italy
Brescia Lombardia, 25123, Italy
Firenze Toscana, 50139, Italy
Fukuoka , 812-8, Japan
Fukuoka , 830-0, Japan
Hiroshima , 734-8, Japan
Hyogo , 665-0, Japan
Kyoto , 602-8, Japan
Miyagi , 980-0, Japan
Osaka , 541-8, Japan
Osaka , 573-1, Japan
Osaka , 589-8, Japan
Osaka , 591-8, Japan
Saitama , 362-0, Japan
Tokyo , 135-8, Japan
Tokyo , 193-0, Japan
Wakayama , 641-8, Japan
Eldoret , 30100, Kenya
Busan , 49267, Korea, Republic of
Daegu , 41404, Korea, Republic of
Daejeon , 35015, Korea, Republic of
Gyeonggi-do , 16247, Korea, Republic of
Gyeongsangnam-do , 51353, 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 , 06591, Korea, Republic of
Cdmx Mexico CITY (federal District), 03100, Mexico
Mexico City Mexico CITY (federal District), 06700, Mexico
Querétaro Queretaro, 76000, Mexico
San Luis Potosà SAN LUIS Potosi, 78209, Mexico
Auckland , 1023, New Zealand
Hamilton , 3204, New Zealand
Palmerston North , 4410, New Zealand
Tauranga , 3112, New Zealand
?ód? , 90-33, Poland
Gdynia , 81-51, Poland
Grudzi?dz , 86-30, Poland
Olsztyn , 10-35, Poland
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Palma de Mallorca Islas Baleares, 07198, Spain
A Coruña LA Coruña, 15006, Spain
Las Palmas de Gran Canaria LAS Palmas, 35016, Spain
Barcelona , 08003, Spain
Barcelona , 08036, Spain
Lugo , 27003, Spain
Madrid , 28007, Spain
Madrid , 28046, Spain
Sevilla , 41014, Spain
Valencia , 46010, Spain
Aarau , 5001, Switzerland
Chur , 7000, Switzerland
Zürich , 8091, Switzerland
Chang Hua , 500, Taiwan
Taichung , 40447, Taiwan
Taipei City , 11217, Taiwan
Bangkok , 10300, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
ChiangMai , 50200, Thailand
Songkhla , 90110, Thailand
Adana , 01220, Turkey
Ankara , 06490, Turkey
Ankara , 06680, Turkey
Diyarbakir , 21280, Turkey
Edirne , 22030, Turkey
Istanbul , 34000, Turkey
Kadiköy , 34722, Turkey
Cornwall , TR1 3, United Kingdom
Hull , HU16 , United Kingdom
London , EC1A , United Kingdom
London , SE1 9, United Kingdom
Manchester , M2O 4, United Kingdom
Nottingham , NG5 1, United Kingdom
Wolverhampton , WV10 , United Kingdom
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