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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04294810
Other study ID # GO41717
Secondary ID 2019-002925-3120
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 4, 2020
Est. completion date February 21, 2025

Study information

Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 620
Est. completion date February 21, 2025
Est. primary completion date February 21, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Atezolizumab
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Tiragolumab
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Matching Placebo
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Locations

Country Name City State
Australia Austin Hospital Olivia Newton John Cancer Centre Heidelberg Victoria
Australia Peter Maccallum Cancer Centre Melbourne Victoria
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria Ordensklinikum Linz Elisabethinen Linz
Austria Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten Wien
Austria Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie Wien
Brazil Hospital de Cancer de Barretos Barretos SP
Brazil Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda Ijui RS
China Beijing Cancer Hospital Beijing
China Beijing Chest Hospital; Oncology Department Beijing
China The First Hospital of Jilin University Changchun City
China Changzhou First People's Hospital Changzhou
China West China Hospital, Sichuan University Chengdu
China Sichuan Cancer Hospital Chengdu City
China Chongqing Cancer Hospital Chongqing
China Fujian Cancer Hospital Fuzhou
China Cancer Center of Guangzhou Medical University Guangzhou
China Hainan General Hospital Haikou
China Sir Run Run Shaw Hospital Zhejiang University Hangzhou City
China Harbin Medical University Cancer Hospital Harbin
China Jinan Central Hospital Jinan City
China Meizhou People's Hospital Meizhou City
China The 1st Affiliated Hospital of Nanchang Unversity Nanchang
China The Second Affiliated Hospital to Nanchang University Nanchang
China Nantong Tumor Hospital Nantong City
China Shanghai Pulmonary Hospital Shanghai
China Zhongshan Hospital Fudan University Shanghai
China Fudan University Shanghai Cancer Center Shanghai City
China Tianjin Cancer Hospital Tianjin
China Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology Wuhan City
China First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xi'an
China The First Affiliated Hospital of Xiamen University Xiamen
China Zhejiang Cancer Hospital Zhejiang
Denmark Aalborg Universitetshospital Aalborg
Denmark Rigshospitalet; Onkologisk Klinik København Ø
Denmark Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed Roskilde
Germany Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie Frankfurt
Germany LungenClinic Großhansdorf GmbH; Klinische Forschung Großhansdorf
Germany Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I Halle (Saale)
Germany Fachklinik für Lungenerkrankungen Immenhausen
Germany SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal Löwenstein
Germany Gemeinschaftspraxis für Hämatologie und Onkologie Münster
Germany Klinik Schillerhöhe; Pneumologische Onkologie Stuttgart
Greece Metropolitan Hospital Athens
Greece Sotiria Hospital Athens
Greece University Hospital of Larissa;Department of Medical Oncology Larissa
Greece Diavalkaniko Hospital Thessaloniki
Hungary Orszagos Koranyi TBC es Pulmonologiai Intezet Budapest
Hungary Matrai Gyogyintezet Matrahaza
Hungary Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály Szolnok
Italy Azienda Ospedaliera San Giuseppe Moscati Avellino Campania
Italy Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia Milano Lombardia
Italy Asst Di Monza Monza Lombardia
Italy Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale Napoli Campania
Italy Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO) Orbassano Piemonte
Italy IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II Padova Veneto
Italy Azienda Ospedaliera San Camillo Forlanini Roma Lazio
Italy Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica Roma Lazio
Italy Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia Rozzano Lombardia
Italy Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica Sant'Andrea Delle Fratte (PG) Umbria
Japan Aichi Cancer Center Aichi
Japan National Cancer Center Hospital East Chiba
Japan Kyushu University Hospital Fukuoka
Japan Sendai Kousei Hospital Miyagi
Japan Niigata Cancer Center Hospital Niigata
Japan Kindai University Hospital Osaka
Japan Osaka International Cancer Institute Osaka
Japan Saitama Cancer Center Saitama
Japan National Hospital Organization Kinki-Chuo Chest Medical Center Sakai-shi
Japan Shizuoka Cancer Center Shizuoka
Japan National Cancer Center Hospital Tokyo
Japan The Cancer Institute Hospital of JFCR Tokyo
Korea, Republic of Chungbuk National University Hospital Cheongju si
Korea, Republic of Ajou University Medical Center Gyeonggi-do
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Chonnam National University Hwasun Hospital Jeollanam-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangbuk Samsung Medical Center Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of St. Vincent's Hospital Suwon
Mexico Health Pharma Professional Research Cdmx Mexico CITY (federal District)
Mexico Cryptex Investigacion Clinica SA de CV Mexico Mexico CITY (federal District)
Mexico AVIX Investigación Clínica S.C Monterrey Nuevo LEON
Mexico Cuidados oncologicos Querétaro Queretaro
Netherlands Jeroen Bosch Ziekenhuis 'S Hertogenbosch
Netherlands Hagaziekenhuis, locatie Leyweg Den-Haag
Netherlands Ziekenhuis Gelderse Vallei EDE
Netherlands Medisch Centrum Leeuwarden Leeuwarden
Peru Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica Arequipa
Peru Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional Lima
Peru Instituto Nacional de Enfermedades Neoplasicas Lima
Peru Clinica Ricardo Palma San Isidro
Poland Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii Gdansk
Poland Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii Olsztyn
Poland Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii Otwock
Poland Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Poznan
Russian Federation Main Military Clinical Hospital named after N.N. Burdenko Moscow Moskovskaja Oblast
Russian Federation MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy Moscow Moskovskaja Oblast
Russian Federation City Clinical Hospital #1 Novosibirsk
Russian Federation Institute of Oncology St Petersburg Sankt Petersburg
Russian Federation Leningrad Regional Clinical Hospital St Petersburg Sankt Petersburg
Russian Federation St. Petersburg Clinical Scientific Center of special services medical assis (oncology) ST Petersburg Sankt Petersburg
Russian Federation St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research St Petersburg Sankt Petersburg
Russian Federation Regional Clinical Oncology Hospital Yaroslavl
Serbia Clinical Center of Serbia Belgrade
Serbia University Hospital Medical Center Bezanijska kosa Belgrade
Serbia Institute for pulmonary diseases of Vojvodina Sremska Kamenica
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Universitario Germans Trias i Pujol Badalona Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital 12 de Octubre; Servicio de Digestivo Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda Madrid
Spain Hospital Regional Universitario de Malaga Malaga
Spain Hospital Universitario Virgen del Rocío Sevilla
Spain Hosp Clinico Univ Lozano Blesa; División De Oncología Médica Zaragoza
Switzerland Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit Bern
Switzerland CHUV; Departement d'Oncologie Lausanne
Switzerland Kantonsspital St.Gallen Medizin Onkologie; Klinik fuer Onkologie und Haematologie St. Gallen
Taiwan Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine Kaohsiung
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City
Taiwan Taipei Medical University ?Shuang Ho Hospital New Taipei City
Taiwan Taichung Veterans General Hospital; Dept of Internal Medicine Taichung
Taiwan National Cheng Kung Uni Hospital; Dept of Hematology and Oncology Tainan
Taiwan Chang Gung Memorial Hospital - Linkou Branch Taipei
Taiwan Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology Taipei
Taiwan National Taiwan University Hospital; Oncology Zhongzheng Dist.
Thailand Chulalongkorn Hospital; Medical Oncology Bangkok
Thailand Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology Bangkok
Thailand Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc Bangkok
Thailand Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory Songkhla
Turkey Adana Baskent University Hospital; Medical Oncology Adana
Turkey Hacettepe University Medical Faculty Ankara
Turkey Istanbul University Cerrahpasa Faculty of Medicine Istanbul
Turkey Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi Izmir
Turkey Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology Kadiköy
Turkey Inonu University Medical Faculty of Medicine; Medical Oncology Department Malatya
Turkey Medical Park Seyhan Hospital; Oncology Department Seyhan
Ukraine City Clinical Hospital #4 Dnipropetrovsk
Ukraine Ivano-Frankivsk Regional Oncology Center Ivano-Frankivsk
Ukraine ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department Kryvyi Rih
Ukraine Uzhgorod Nat. University Central Municip Hosp; Onc Center Uzhgorod
United States Virginia Cancer Specialists (Fairfax) - USOR Fairfax Virginia
United States Rocky Mountain Cancer Center - Denver Littleton Colorado
United States SCRI Oncology Partners Nashville Tennessee
United States Yale Cancer Center New Haven Connecticut
United States US oncology research at Minnesota Oncology Saint Paul Minnesota
United States SCRI Florida Cancer Specialists North; Research Office North Region. Saint Petersburg Florida
United States Onc & Hem Assoc SW Virginia Salem Virginia
United States SCRI Florida Cancer Specialists PAN Tallahassee Florida
United States Northwest Cancer Specialists - Vancouver Vancouver Washington

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  China,  Denmark,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Peru,  Poland,  Russian Federation,  Serbia,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Primary Overall Survival (OS) in the Primary Analysis Set From randomization to death from any cause (up to approximately 59 months)
Primary Percentage of Participants With Adverse Events (AEs) Up to approximately 59 months
Primary Percentage of Participants With Cytokine-Release Syndrome (CRS) Up to approximately 59 months
Secondary Investigator-Assessed PFS in the Secondary Analysis Set From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Secondary OS in the Secondary Analysis Set From randomization to death from any cause (up to approximately 59 months)
Secondary Investigator-Assessed Confirmed Objective Response Rate (ORR) From randomization up to approximately 59 months
Secondary Investigator-Assessed Duration of Response (DOR) From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Secondary Investigator-Assessed PFS Rates at 6 Months and 12 Months 6 months, 12 months
Secondary OS Rates at 12 Months and 24 Months 12 months, 24 months
Secondary Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome. From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)
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