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:

540

Study ID:

NCT04619797

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 119 Locations for this study

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St. Bernard's Hospital, Inc. d/b/a St. Bernards Medical Center
Jonesboro Arkansas, 72401, United States
UCLA
Los Angeles California, 90095, United States
Kaiser Permanente - Oakland
Oakland California, 94611, United States
Torrance Health Association
Redondo Beach California, 90277, United States
Kaiser Permanente - Roseville
Roseville California, 95661, United States
Kaiser Permanente - Sacramento; Oncology Pharmacy
Sacramento California, 95814, United States
Kaiser Permanente - San Francisco (2238 Geary)
San Francisco California, 94115, United States
Kaiser Permanente - San Jose Medical Center
San Jose California, 95119, United States
Kaiser Permanente - San Leandro
San Leandro California, 94577, United States
Kaiser Permanente - Santa Clara; Oncology Clinical trials
Santa Clara California, 95051, United States
Kaiser Permanente - South San Francisco
South San Francisco California, 94080, United States
Kaiser Permanente - Vallejo
Vallejo California, 94589, United States
Kaiser Permanente - Walnut Creek
Walnut Creek California, 94596, United States
PIH Health Whittier Hospital; NC
Whittier California, 90602, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Orlando Health Inc.
Orlando Florida, 32806, 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
Boston Medical Center
Boston Massachusetts, 02118, United States
Cancer Care Specialists; Division of Clinical Research
Reno Nevada, 89511, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Sarah Cannon Res. Inst. Onc.
Nashville Tennessee, 37203, United States
Bon Secours Mercy Health
Midlothian Virginia, 23114, United States
Summit Cancer Centers
Spokane Washington, 99208, United States
Onze Lieve Vrouwziekenhuis Aalst
Aalst , 9300, Belgium
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
CHU de Liège
Liège , 4000, Belgium
CHU UCL Mont-Godinne
Mont-godinne , 5530, Belgium
Vitaz
Sint Niklaas , 9100, Belgium
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
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
Jilin Cancer Hospital
Changchun , 13201, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou City , 31001, China
The Second People's Hospital Of Liaocheng
Liaocheng , 05490, China
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang , 47100, 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
Institut Curie; Oncologie Medicale
Paris , 75231, 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
Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin
Bochum , 44791, 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
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
Sendai Kousei Hospital
Miyagi , 980-0, 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
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
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
Severance Hospital, Yonsei University Health System
Seoul , 003-7, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, 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.
Mexico City , 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
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
Adana Baskent University Medical Faculty; Oncology
Adana , 01220, Turkey
Ankara 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:

540

Study ID:

NCT04619797

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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