Lung Cancer Clinical Trial
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
Summary
The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
No progression during or following concurrent platinum-based CRT
A known PD-L1 result
Life expectancy >/= 12 weeks
Adequate hematologic and end-organ function
Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab
Exclusion Criteria:
Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
Any evidence of Stage IV disease
Treatment with sequential CRT for locally advanced NSCLC
Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
Any Grade >2 unresolved toxicity from previous CRT
Grade >= 2 pneumonitis from prior CRT
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 screening with the exception of malignancies with a negligible risk of metastasis or death
Prior allogeneic stem cell or solid organ transplantation
Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
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-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
Treatment with systemic immunosuppressive medication
Women who are pregnant, or breastfeeding
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There are 207 Locations for this study
Tucson Arizona, 85715, United States
Hot Springs Arkansas, 71913, United States
Palo Alto California, 94305, United States
Greeley Colorado, 85234, United States
Fort Myers Florida, 33901, United States
Pensacola Florida, 32503, United States
Rockledge Florida, 32955, United States
Saint Petersburg Florida, 33705, United States
Marietta Georgia, 30060, United States
Peoria Illinois, 61615, United States
Brunswick Maine, 04011, United States
Fairhaven Massachusetts, 02719, United States
Saint Paul Minnesota, 55102, United States
Kansas City Missouri, 64132, United States
Springfield Missouri, 65807, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89128, United States
East Brunswick New Jersey, 08816, United States
Farmington New Mexico, 87401, United States
Albany New York, 12208, United States
Bronx New York, 10467, United States
New York New York, 10029, United States
Greenville South Carolina, 29615, United States
Rapid City South Dakota, 57701, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Buenos Aires , C1431, Argentina
Ciudad Autonoma Buenos Aires , C1284, Argentina
Cordoba , X5004, Argentina
Rosario , S2000, Argentina
Blacktown New South Wales, 2148, Australia
Campbelltown New South Wales, 2560, Australia
Kogarah New South Wales, 2217, Australia
Woolloongabba Queensland, 4102, Australia
Bedford Park South Australia, 5042, Australia
Bull Creek Western Australia, 6149, Australia
Victoria , 3168, Australia
Innsbruck , 6020, Austria
Krems , 3500, Austria
Linz , 4020, Austria
Wien , 1140, Austria
Aalst , 9300, Belgium
Charleroi , 6000, Belgium
Gent , 9000, Belgium
Hasselt , 3500, Belgium
Mons , 7000, Belgium
Salvador BA, 41253, Brazil
Fortaleza CE, 60336, Brazil
Curitiba PR, 80810, Brazil
Ijui RS, 98700, Brazil
Porto Alegre RS, 90610, Brazil
Barretos SP, 14784, Brazil
Sao Jose do Rio Preto SP, 15090, Brazil
Sao Paulo SP, 01246, Brazil
Abbotsford British Columbia, V2S 0, Canada
Surrey British Columbia, V3V 1, Canada
Victoria British Columbia, V8R 6, Canada
Winnipeg Manitoba, R3E 0, Canada
Barrie Ontario, L4M 6, Canada
Brampton Ontario, L6R 3, Canada
Ottawa Ontario, K1Y 4, Canada
Sudbury Ontario, P3E 5, Canada
Timmins Ontario, P4N 8, Canada
Beijing City , 10003, China
Beijing City , 10014, China
Beijing , 10114, China
Changchun , 13201, China
Changsha City , 41000, China
Changzhou , 21300, China
Chengdu , 61004, China
Chongqing , 40003, China
Fuzhou City , 35000, China
Fuzhou City , 35001, China
Guangzhou City , 51006, China
Hangzhou City , 31000, China
Hangzhou City , 31001, China
Jinan , 25011, China
Nanjing City , 21002, China
Nanjing , 21000, China
Qingdao City , 26604, China
Shanghai , 20000, China
Shanghai , 20043, China
Shantou , 51504, China
Taiyuan , 03001, China
Tianjin , 30006, China
Wenzhou City , 32500, China
Wuhan City , 43002, China
Wuhan , 43007, China
Xiamen , 36100, China
Xuzhou , 22100, China
Zhengzhou , 45000, China
Amiens , 80054, France
Angers , 49933, France
Caen , 14000, France
Marseille , 13015, France
Montpellier , 34070, France
Vantoux , 57070, France
Villejuif cedex , 94805, France
Braunschweig , 38114, Germany
Göttingen , 37075, Germany
Heidelberg , 69126, Germany
Köln , 51109, Germany
München , 81925, Germany
Regensburg , 93053, Germany
Asvestochori , 570 1, Greece
Athens , 104 3, Greece
Heraklion , 711 1, Greece
Kifisia , 145 6, Greece
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Pokfulam , , Hong Kong
Pécs , 7623, Hungary
Szolnok , 5000, Hungary
Tatabánya , 2800, Hungary
Torokbalint , 2045, Hungary
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Napoli Campania, 80131, Italy
Meldola Emilia-Romagna, 47014, Italy
Parma Emilia-Romagna, 43126, Italy
Roma Lazio, 00128, Italy
Roma Lazio, 00144, Italy
Genova Liguria, 16132, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, , Italy
Pavia Lombardia, 27100, Italy
Pisa Toscana, 56124, Italy
Vicenza Veneto, 36100, Italy
Aichi , 464-8, Japan
Chiba , 277-8, Japan
Hyogo , 670-8, Japan
Kanagawa , 252-0, Japan
Kyoto , 606-8, Japan
Miyagi , 980-0, Japan
Niigata , 951-8, Japan
Osaka , 589-8, Japan
Saitama , 362-0, Japan
Shizuoka , 411-8, Japan
Tokyo , 104-0, Japan
Tokyo , 135-8, Japan
Wakayama , 641-8, Japan
Cheongju-si , 28644, Korea, Republic of
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Gyeonggi-do , 16247, Korea, Republic of
Gyeonggi-do , 16499, Korea, Republic of
Gyeongsangnam-do , 50612, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seongnam-si , 463-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 08308, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Amersfoort , 3813 , Netherlands
Breda , 4819 , Netherlands
Leidschendam , 2262 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Auckland , 1023, New Zealand
Gda?sk , 80-21, Poland
Olsztyn , 10-22, Poland
Otwock , 05-40, Poland
Warszawa , 02-78, Poland
Wroc?aw , 53-41, Poland
Coimbra , 3000-, Portugal
Lisboa , 1500-, Portugal
Porto , 4100-, Portugal
Porto , 4200-, Portugal
Badalona Barcelona, 08916, Spain
Castellon de La Plana Castellon, 12002, Spain
Palma de Mallorca Islas Baleares, 07198, Spain
A Coruña LA Coruña, 15006, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Malaga , 29011, Spain
Sevilla , 41013, Spain
Sevilla , 41014, Spain
Taichung , 40447, Taiwan
Taipei , 100, Taiwan
Taipei , 112, Taiwan
Bangkok , 10300, Thailand
Bangkok , 10400, Thailand
Bangkok , 10400, Thailand
Songkhla , 90110, Thailand
Adana , 01220, Turkey
Ankara , 06100, Turkey
Ankara , 06100, Turkey
Ankara , 06490, Turkey
Ankara , 06500, Turkey
Bornova, ?zm?r , 35100, Turkey
Diyarbakir , 21280, Turkey
Edirne , 22030, Turkey
Istanbul , 34098, Turkey
Istanbul , 34214, Turkey
Malatya , 44280, Turkey
Birmingham , B9 5S, United Kingdom
Cambridge , CB2 0, United Kingdom
Glasgow , G12 0, United Kingdom
Huddersfield , HD3 3, United Kingdom
Leicester , LE1 5, United Kingdom
London , NW3 2, United Kingdom
Maidstone , ME16 , United Kingdom
Manchester , M20 4, United Kingdom
Nottingham , NG5 1, United Kingdom
Sheffield , S10 2, United Kingdom
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