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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

635

Study ID:

NCT04294810

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 170 Locations for this study

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Rocky Mountain Cancer Center - Denver
Littleton Colorado, 80120, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
SCRI Florida Cancer Specialists North; Research Office North Region.
Saint Petersburg Florida, 33705, United States
SCRI Florida Cancer Specialists PAN
Tallahassee Florida, 32308, United States
Illinois Cancer Specialists
Arlington Heights Illinois, 60005, United States
Karmanos Cancer Institute..
Detroit Michigan, 48201, United States
US oncology research at Minnesota Oncology
Saint Paul Minnesota, 55102, United States
Onc/Hem Care Clin Trials LLC
Cincinnati Ohio, 45242, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Texas Onc-Central Austin CA Ct
Austin Texas, 78731, United States
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax Virginia, 22031, United States
Onc & Hem Assoc SW Virginia
Salem Virginia, 24153, United States
Northwest Cancer Specialists - Vancouver
Vancouver Washington, 98684, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Fundación Respirar
Capital Federal , 1426, Argentina
CEMER Centro Medico de Enfermedades Respiratorias
Vicente López , B1602, Argentina
Clínica Viedma
Viedma Rio Negro , R8500, Argentina
St Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Frankston Hospital; Oncology/Haematology
Frankston Victoria, 3199, Australia
Austin Hospital Olivia Newton John Cancer Centre
Heidelberg Victoria, 3084, Australia
Peter Maccallum Cancer Centre
Melbourne Victoria, 3000, Australia
Ordensklinikum Linz Elisabethinen
Linz , 4020, Austria
Klinikum Wels-Grieskirchen; Lungenabt.
Wels , 4600, Austria
SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung
Wien , 1140, Austria
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
Wien , 1210, Austria
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijui RS, 98700, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Beijing Cancer Hospital
Beijing , 10014, China
Beijing Chest Hospital; Oncology Department
Beijing , 10114, China
The First Hospital of Jilin University
Changchun City , 13002, China
Changzhou First People's Hospital
Changzhou , 21300, China
West China Hospital, Sichuan University
Chengdu , 61004, China
Fujian Cancer Hospital
Fuzhou , 35001, China
Cancer Center of Guangzhou Medical University
Guangzhou , 51000, China
Hainan General Hospital
Haikou , 57031, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou City , 31001, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Jinan Central Hospital
Jinan City , 25001, China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang , 33001, China
Nantong Tumor Hospital
Nantong City , 22636, China
Fudan University Shanghai Cancer Center
Shanghai City , 20012, China
Zhongshan Hospital Fudan University
Shanghai , 20003, China
Shanghai Pulmonary Hospital
Shanghai , 20043, China
Tianjin Cancer Hospital
Tianjin , 30006, China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan City , 43002, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an , 71006, China
The First Affiliated Hospital of Xiamen University
Xiamen , 36100, China
Zhejiang Cancer Hospital
Zhejiang , 31002, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Aalborg Universitetshospital
Aalborg , 9000, Denmark
Rigshospitalet; Onkologisk Klinik
København Ø , 2100, Denmark
Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed
Roskilde , 4000, Denmark
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux , 33076, France
Centre Hospitalier Intercommunal; Service de Pneumologie
Creteil , 94010, France
Centre Georges Francois Leclerc; Recherche Clinique
Dijon , 21079, France
CHRU Nantes
Nantes , 44093, France
CH de Saint Quentin
Saint Quentin , 2100, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg , 67065, France
CHU de Toulouse - Hôpital Larrey
Toulouse , 31059, France
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt , 60488, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
Halle (Saale) , 06120, Germany
Fachklinik für Lungenerkrankungen
Immenhausen , 34376, Germany
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal
Löwenstein , 74245, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster , 48153, Germany
Klinik Schillerhöhe; Pneumologische Onkologie
Stuttgart , 70376, Germany
Sotiria Hospital
Athens , 104 3, Greece
Metropolitan Hospital
Athens , 185 4, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion , 711 1, Greece
University Hospital of Larissa;Department of Medical Oncology
Larissa , 411 1, Greece
Diavalkaniko Hospital
Thessaloniki , 570 0, Greece
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest , 1121, Hungary
Veszprem Megyei Onkormanyzat Tudogyogyintezete; Tudogyogyaszati Ambulancia
Farkasgyepu , 8582, Hungary
Matrai Gyogyintezet
Matrahaza , 3233, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
Szolnok , 5004, Hungary
Azienda Ospedaliera San Giuseppe Moscati
Avellino Campania, 83100, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
A.O. Universitaria Di Parma; Oncologia Medica
Parma Emilia-Romagna, 43100, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma Lazio, 00152, Italy
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
Roma Lazio, 00168, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
Milano Lombardia, 20141, Italy
Asst Di Monza
Monza Lombardia, 20900, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano Lombardia, 20089, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)
Orbassano Piemonte, 10043, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG) Umbria, 06132, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova Veneto, 35128, Italy
Aichi Cancer Center
Aichi , 464-8, Japan
National Cancer Center Hospital East
Chiba , 277-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Sendai Kousei Hospital
Miyagi , 980-0, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Okayama University Hospital
Okayama , 700-8, 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
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Ajou University Medical Center
Gyeonggi-do , 16499, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Medical Center
Seoul , 03181, 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
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
St. Vincent's Hospital
Suwon , 442-7, Korea, Republic of
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Cryptex Investigacion Clinica SA de CV
Mexico Mexico CITY (federal District), 06100, Mexico
Cuidados oncologicos
Querétaro Queretaro, 76000, Mexico
AVIX Investigación Clínica S.C
Monterrey , 64710, Mexico
Jeroen Bosch Ziekenhuis
'S Hertogenbosch , 5223 , Netherlands
Hagaziekenhuis, locatie Leyweg
Den-Haag , 2545 , Netherlands
Ziekenhuis Gelderse Vallei
EDE , 6716 , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden , 8934 , Netherlands
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
Arequipa , 5154, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima , Lima , Peru
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima , Lima , Peru
Clinica Ricardo Palma
San Isidro , Lima , Peru
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk , 80-21, 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
Main Military Clinical Hospital named after N.N. Burdenko
Moscow Moskovskaja Oblast, 10522, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
Moscow Moskovskaja Oblast, 14342, Russian Federation
City Clinical Hospital #1
Novosibirsk , 63004, Russian Federation
Institute of Oncology
St Petersburg , 18964, Russian Federation
Leningrad Regional Clinical Hospital
St Petersburg , 19429, Russian Federation
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
St Petersburg , 19708, Russian Federation
St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
ST Petersburg , 19775, Russian Federation
Regional Clinical Oncology Hospital
Yaroslavl , 15004, Russian Federation
Clinical Center of Serbia
Belgrade , 11000, Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade , 11080, Serbia
Institute for pulmonary diseases of Vojvodina
Sremska Kamenica , 21204, Serbia
Hospital Universitario Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda Madrid, 28220, Spain
Hospital General Universitario de Alicante
Alicante , 03010, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital 12 de Octubre; Servicio de Digestivo
Madrid , 28041, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Zaragoza , 50009, Spain
Universitaetsspital Basel; Onkologie
Basel , 4031, Switzerland
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern , 3010, Switzerland
CHUV; Departement d'Oncologie
Lausanne , 1011, Switzerland
Kantonsspital St.Gallen Medizin Onkologie; Klinik fuer Onkologie und Haematologie
St. Gallen , 9000, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City , 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung , 83301, Taiwan
Taipei Medical University -Shuang Ho Hospital
New Taipei City , 23561, Taiwan
Taichung Veterans General Hospital; Dept of Internal Medicine
Taichung , 407, Taiwan
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
Tainan , 704, Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei , 112, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taipei , , Taiwan
National Taiwan University Hospital; Oncology
Zhongzheng Dist. , 10048, Taiwan
Chulalongkorn Hospital; Medical Oncology
Bangkok , 10330, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok , 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok , 10700, Thailand
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
Songkhla , 90110, Thailand
Adana Baskent University Hospital; Medical Oncology
Adana , 01120, Turkey
Hacettepe University Medical Faculty
Ankara , 06100, Turkey
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul , 34098, Turkey
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir , 35110, Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
Kadiköy , 34722, Turkey
Inonu University Medical Faculty of Medicine; Medical Oncology Department
Malatya , 44280, Turkey
City Clinical Hospital #4
Dnipropetrovsk , 49102, Ukraine
Ivano-Frankivsk Regional Oncology Center
Ivano-Frankivsk , 76018, Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
Kryvyi Rih , 50048, Ukraine
Sumy Regional Clinical Onc Ctr
Sumy , 40005, Ukraine
Uzhgorod Nat. University Central Municip Hosp; Onc Center
Uzhgorod , 88000, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

635

Study ID:

NCT04294810

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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