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).

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

542

Study ID:

NCT04619797

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 140 Locations for this study

See Locations Near You

UCLA
Los Angeles California, 90095, United States
Torrance Memorial Physician Network/Cancer Care
Torrance California, 90505, United States
PIH Health Whittier Hospital; NC
Whittier California, 90602, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Advent Health Orlando
Orlando Florida, 32804, United States
SCRI Florida Cancer Specialists North; Research Office North Region.
Saint Petersburg Florida, 33705, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne Indiana, 46804, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Sarah Cannon Res. Inst. Onc.
Nashville Tennessee, 37203, United States
Inova Schar Cancer Institute; Inova Schar Cancer Institute Infusion Pharmacy
Fairfax Virginia, 22031, United States
Onze Lieve Vrouwziekenhuis Aalst
Aalst , 9300, Belgium
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
Jessa Ziekenhuis
Hasselt , 3500, Belgium
CHU de Liège
Liège , 4000, Belgium
CHU UCL Mont-Godinne
Mont-godinne , 5530, Belgium
Vitaz
Sint Niklaas , 9100, Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza CE, 60336, Brazil
Oncocentro Belo Horizonte
Belo Horizonte MG, 30360, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijui RS, 98700, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 90040, Brazil
Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
Victoria Hospital - London Health Sciences Centre
London Ontario, N6A 4, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G 2, Canada
Sault Area Hospital; Algoma District Cancer Program
Sault Ste. Marie Ontario, P6B 0, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
Beijing Cancer Hospital
Beijing , 10014, China
Jilin Cancer Hospital
Changchun , 13201, China
Xiangya Hospital Central South University
Changsha City , 41000, China
Changzhou First People's Hospital; Oncology
Changzhou , 21300, China
Affiliated Hospital of Chengde Medical University
Chengde City , 06702, China
Sichuan Cancer Hospital
Chengdu City , 61004, China
West China Hospital - Sichuan University
Chengdu City , 61004, China
Dongguan People's Hospital
Dongguan , 51170, China
Anhui Provincial Hospital; Respiratory Department
Hefei , 23008, China
Jinan Central Hospital
Jinan City , 25001, China
Linyishi Cancer Hospital
Linyi City , 27603, China
Pingxiang People Hospital
Pingxiang City , 33700, China
Qingdao Central Hospital; Department of Respiratory and Critical Care Medicine
Qingdao City , 26604, China
Weifang People's Hospital
Weifang City , 26104, China
Hubei Cancer Hospital
Wuhan , 43007, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an City , 71006, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang City , 45300, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou , 45005, China
Rigshospitalet; Onkologisk Klinik
København Ø , 2100, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C , 5000, Denmark
Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed
Roskilde , 4000, Denmark
Institut Bergonie; Pneumology
Bordeaux , 33076, France
Hopital Nord; Pneumologie
Marseille cedex 20 , 13915, France
Hopital de Pontchaillou; Service de Pneumologie
Rennes , 35033, France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg , 67091, France
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
Toulouse cedex 9 , 31100, France
Helios Klinikum Emil von Behring GmbH
Berlin , 14165, Germany
Klinikum Chemnitz gGmbH
Chemnitz , 09116, Germany
St. Vincentius Kliniken Karlsruhe
Karlsruhe , 76137, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz , 55131, Germany
Klinikum der Philipps-Universität Marburg
Marburg , 35032, Germany
Hong Kong United Oncology Centre
Hong Kong , , Hong Kong
Queen Mary Hospital; Dept. of Clinical Oncology
Hong Kong , , Hong Kong
Queen Mary Hospital; Medicine & Respiratory
Hong Kong , , Hong Kong
Tuen Mun Hospital; Clinical Onc
Hong Kong , , Hong Kong
Prince of Wales Hospital; Department of Clinical Onocology
Shatin , , Hong Kong
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna Emilia-Romagna, 40138, Italy
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
Aviano Friuli-Venezia Giulia, 33081, Italy
A.O. Villa Scassi; Oncologia Medica
Genova Liguria, 16149, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo Lombardia, 24127, Italy
ASST Spedali Civili di Brescia
Brescia Lombardia, 25123, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Firenze Toscana, 50139, Italy
Kyushu University Hospital
Fukuoka , 812-8, Japan
Kurume University Hospital
Fukuoka , 830-0, Japan
Hiroshima University Hospital
Hiroshima , 734-8, Japan
Takarazuka City Hospital
Hyogo , 665-0, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto , 602-8, Japan
Sendai Kousei Hospital
Miyagi , 980-0, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Kansai Medical University Hospital
Osaka , 573-1, Japan
Kindai University Hospital
Osaka , 589-8, Japan
Kinki-Chuo Chest Medical Center
Osaka , 591-8, Japan
Saitama Cancer Center
Saitama , 362-0, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo , 193-0, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
International Cancer Institute (ICI)
Eldoret , 30100, Kenya
Kosin University Gospel Hospital
Busan , 49267, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of
St. Vincent's Hospital
Gyeonggi-do , 16247, Korea, Republic of
Samsung Changwon Hospital
Gyeongsangnam-do , 51353, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Seoul St Mary's Hospital
Seoul , 06591, Korea, Republic of
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Cuidados oncologicos
Querétaro Queretaro, 76000, Mexico
Oncologico Potosino
San Luis Potosí SAN LUIS Potosi, 78209, Mexico
ARKE Estudios Clínicos S.A. de C.V.
Ciudad de México , 06700, Mexico
Auckland City Hospital, Cancer and Blood Research
Auckland , 1023, New Zealand
Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre
Hamilton , 3204, New Zealand
Palmerston North Hospital
Palmerston North , 4410, New Zealand
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
Tauranga , 3112, New Zealand
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
?ód? , 90-33, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn , 10-35, Poland
ICO L'Hospitalet; Servicio de oncologia medica
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Hospital Son Llatzer; Servicio de Oncologia
Palma de Mallorca Islas Baleares, 07198, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña LA Coruña, 15006, Spain
Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
Las Palmas de Gran Canaria LAS Palmas, 35016, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona , 08003, Spain
Hospital Clinic Barcelona; Servicio de oncologia
Barcelona , 08036, Spain
Hospital Lucus Augusti; Servicio de Oncologia
Lugo , 27003, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
Sevilla , 41014, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia , 46010, Spain
Kantonsspital Aarau
Aarau , 5001, Switzerland
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
Chur , 7000, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich , 8091, Switzerland
Changhua Christian Hospital
Chang Hua , 500, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Taipei Veterans General Hospital
Taipei City , 11217, Taiwan
Vajira Hospital
Bangkok , 10300, Thailand
Chulalongkorn Hospital; Medical Oncology
Bangkok , 10330, Thailand
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
Bangkok , 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok , 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
ChiangMai , 50200, Thailand
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
Songkhla , 90110, Thailand
Adana Baskent University Medical Faculty; Oncology
Adana , 01220, Turkey
Ankara Bilkent City Hospital
Ankara , 06490, Turkey
Liv Hospital Ankara; Medical Oncology
Ankara , 06680, Turkey
Dicle University Faculty of Medicine
Diyarbakir , 21280, Turkey
Trakya University Medical Faculty
Edirne , 22030, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34000, Turkey
Medeniyet University Goztepe Training and Research Hospital.
Kadiköy , 34722, Turkey
Royal Cornwall Hospital; Dept of Clinical Oncology
Cornwall , TR1 3, United Kingdom
Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
Hull , HU16 , United Kingdom
Barts & London School of Med; Medical Oncology
London , EC1A , United Kingdom
Guy'S Hospital; Oncology Unit
London , SE1 9, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

542

Study ID:

NCT04619797

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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