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

Phase 3

Active, not recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Atezolizumab; Drug: Matching Placebo; Drug: Tiragolumab

• Registration Number: NCT04294810
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Study Start: 2020-03-04
• Study First Posted: 2020-03-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 620

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiragolumab + Atezolizumab	Atezolizumab	Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
Placebo + Atezolizumab	Atezolizumab	Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
Placebo + Atezolizumab	Matching Placebo	Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
Tiragolumab + Atezolizumab	Tiragolumab	Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
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)
Overall Survival (OS) in the Primary Analysis Set	From randomization to death from any cause (up to approximately 59 months)
Percentage of Participants With Adverse Events (AEs)	Up to approximately 59 months
Percentage of Participants With Cytokine-Release Syndrome (CRS)	Up to approximately 59 months

Secondary Outcome Measures

Name	Time	Method
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)
OS in the Secondary Analysis Set	From randomization to death from any cause (up to approximately 59 months)
Investigator-Assessed Confirmed Objective Response Rate (ORR)	From randomization up to approximately 59 months
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)
Investigator-Assessed PFS Rates at 6 Months and 12 Months	6 months, 12 months
OS Rates at 12 Months and 24 Months	12 months, 24 months
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)	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.

Trial Locations

Locations (157)

US oncology research at Minnesota Oncology; 🇺🇸 Saint Paul, Minnesota, United States

Onc & Hem Assoc SW Virginia; 🇺🇸 Salem, Virginia, United States

Austin Hospital Olivia Newton John Cancer Centre; 🇦🇺 Heidelberg, Victoria, Australia

Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten; 🇦🇹 Wien, Austria

Hainan General Hospital; 🇨🇳 Haikou, China

Meizhou People's Hospital; 🇨🇳 Meizhou City, China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

LungenClinic Großhansdorf GmbH; Klinische Forschung; 🇩🇪 Großhansdorf, Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I; 🇩🇪 Halle (Saale), Germany

SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal; 🇩🇪 Löwenstein, Germany

University Hospital of Larissa;Department of Medical Oncology; 🇬🇷 Larissa, Greece

Aichi Cancer Center; 🇯🇵 Aichi, Japan

National Cancer Center Hospital East; 🇯🇵 Chiba, Japan

Chungbuk National University Hospital; 🇰🇷 Cheongju si, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Jeroen Bosch Ziekenhuis; 🇳🇱 'S Hertogenbosch, Netherlands

Instituto Nacional de Enfermedades Neoplasicas; 🇵🇪 Lima, Peru

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii; 🇵🇱 Otwock, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; 🇵🇱 Poznan, Poland

Institute of Oncology; 🇷🇺 St Petersburg, Sankt Petersburg, Russian Federation

Leningrad Regional Clinical Hospital; 🇷🇺 St Petersburg, Sankt Petersburg, Russian Federation

St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research; 🇷🇺 St Petersburg, Sankt Petersburg, Russian Federation

St. Petersburg Clinical Scientific Center of special services medical assis (oncology); 🇷🇺 ST Petersburg, Sankt Petersburg, Russian Federation

Institute for pulmonary diseases of Vojvodina; 🇷🇸 Sremska Kamenica, Serbia

University Hospital Medical Center Bezanijska kosa; 🇷🇸 Belgrade, Serbia

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Regional Universitario de Malaga; 🇪🇸 Malaga, Spain

Hospital 12 de Octubre; Servicio de Digestivo; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hosp Clinico Univ Lozano Blesa; División De Oncología Médica; 🇪🇸 Zaragoza, Spain

CHUV; Departement d'Oncologie; 🇨🇭 Lausanne, Switzerland

Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit; 🇨🇭 Bern, Switzerland

Kantonsspital St.Gallen Medizin Onkologie; Klinik fuer Onkologie und Haematologie; 🇨🇭 St. Gallen, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine; 🇨🇳 Kaohsiung, Taiwan

Taichung Veterans General Hospital; Dept of Internal Medicine; 🇨🇳 Taichung, Taiwan

Taipei Medical University ?Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan

Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou Branch; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; Oncology; 🇨🇳 Zhongzheng Dist., Taiwan

Chulalongkorn Hospital; Medical Oncology; 🇹🇭 Bangkok, Thailand

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc; 🇹🇭 Bangkok, Thailand

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology; 🇹🇭 Bangkok, Thailand

Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory; 🇹🇭 Songkhla, Thailand

Adana Baskent University Hospital; Medical Oncology; 🇹🇷 Adana, Turkey

Hacettepe University Medical Faculty; 🇹🇷 Ankara, 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

Medical Park Seyhan Hospital; Oncology Department; 🇹🇷 Seyhan, Turkey

Inonu University Medical Faculty of Medicine; Medical Oncology Department; 🇹🇷 Malatya, Turkey

City Clinical Hospital #4; 🇺🇦 Dnipropetrovsk, Ukraine

Ivano-Frankivsk Regional Oncology Center; 🇺🇦 Ivano-Frankivsk, Ukraine

The First Hospital of Jilin University; 🇨🇳 Changchun City, China

Virginia Cancer Specialists (Fairfax) - USOR; 🇺🇸 Fairfax, Virginia, United States

Aalborg Universitetshospital; 🇩🇰 Aalborg, Denmark

Rigshospitalet; Onkologisk Klinik; 🇩🇰 København Ø, Denmark

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department; 🇺🇦 Kryvyi Rih, Ukraine

Northwest Cancer Specialists - Vancouver; 🇺🇸 Vancouver, Washington, United States

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Sichuan Cancer Hospital; 🇨🇳 Chengdu City, China

Beijing Chest Hospital; Oncology Department; 🇨🇳 Beijing, China

Changzhou First People's Hospital; 🇨🇳 Changzhou, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, China

Cancer Center of Guangzhou Medical University; 🇨🇳 Guangzhou, China

Sir Run Run Shaw Hospital Zhejiang University; 🇨🇳 Hangzhou City, China

Jinan Central Hospital; 🇨🇳 Jinan City, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

The Second Affiliated Hospital to Nanchang University; 🇨🇳 Nanchang, China

The 1st Affiliated Hospital of Nanchang Unversity; 🇨🇳 Nanchang, China

Nantong Tumor Hospital; 🇨🇳 Nantong City, China

Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan City, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai City, China

Tianjin Cancer Hospital; 🇨🇳 Tianjin, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, China

Zhejiang Cancer Hospital; 🇨🇳 Zhejiang, China

Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed; 🇩🇰 Roskilde, Denmark

Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie; 🇩🇪 Frankfurt, Germany

Fachklinik für Lungenerkrankungen; 🇩🇪 Immenhausen, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie; 🇩🇪 Münster, Germany

Sotiria Hospital; 🇬🇷 Athens, Greece

Metropolitan Hospital; 🇬🇷 Athens, Greece

Diavalkaniko Hospital; 🇬🇷 Thessaloniki, Greece

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály; 🇭🇺 Szolnok, Hungary

Azienda Ospedaliera San Giuseppe Moscati; 🇮🇹 Avellino, Campania, Italy

Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica; 🇮🇹 Roma, Lazio, Italy

Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia; 🇮🇹 Milano, Lombardia, Italy

Asst Di Monza; 🇮🇹 Monza, Lombardia, Italy

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica; 🇮🇹 Sant'Andrea Delle Fratte (PG), Umbria, Italy

Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO); 🇮🇹 Orbassano, Piemonte, Italy

Kyushu University Hospital; 🇯🇵 Fukuoka, Japan

Sendai Kousei Hospital; 🇯🇵 Miyagi, Japan

Saitama Cancer Center; 🇯🇵 Saitama, Japan

The Cancer Institute Hospital of JFCR; 🇯🇵 Tokyo, Japan

Ajou University Medical Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Cryptex Investigacion Clinica SA de CV; 🇲🇽 Mexico, Mexico CITY (federal District), Mexico

Hagaziekenhuis, locatie Leyweg; 🇳🇱 Den-Haag, Netherlands

Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica; 🇵🇪 Arequipa, Peru

MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy; 🇷🇺 Moscow, Moskovskaja Oblast, Russian Federation

City Clinical Hospital #1; 🇷🇺 Novosibirsk, Russian Federation

Regional Clinical Oncology Hospital; 🇷🇺 Yaroslavl, Russian Federation

Hospital Universitario Puerta de Hierro - Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Istanbul University Cerrahpasa Faculty of Medicine; 🇹🇷 Istanbul, Turkey

Uzhgorod Nat. University Central Municip Hosp; Onc Center; 🇺🇦 Uzhgorod, Ukraine

Osaka International Cancer Institute; 🇯🇵 Osaka, Japan

Cuidados oncologicos; 🇲🇽 Querétaro, Queretaro, Mexico

Ziekenhuis Gelderse Vallei; 🇳🇱 EDE, Netherlands

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II; 🇮🇹 Padova, Veneto, Italy

Clinica Ricardo Palma; 🇵🇪 San Isidro, Peru

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale; 🇮🇹 Napoli, Campania, Italy

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia; 🇮🇹 Rozzano, Lombardia, Italy

Niigata Cancer Center Hospital; 🇯🇵 Niigata, Japan

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Orszagos Koranyi TBC es Pulmonologiai Intezet; 🇭🇺 Budapest, Hungary

SCRI Oncology Partners; 🇺🇸 Nashville, Tennessee, United States

SCRI Florida Cancer Specialists North; Research Office North Region.; 🇺🇸 Saint Petersburg, Florida, United States

Klinik Schillerhöhe; Pneumologische Onkologie; 🇩🇪 Stuttgart, Germany

Azienda Ospedaliera San Camillo Forlanini; 🇮🇹 Roma, Lazio, Italy

Kindai University Hospital; 🇯🇵 Osaka, Japan

Ordensklinikum Linz Elisabethinen; 🇦🇹 Linz, Austria

Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie; 🇦🇹 Wien, Austria

Matrai Gyogyintezet; 🇭🇺 Matrahaza, Hungary

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan

Health Pharma Professional Research; 🇲🇽 Cdmx, Mexico CITY (federal District), Mexico

Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii; 🇵🇱 Gdansk, Poland

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

SCRI Florida Cancer Specialists PAN; 🇺🇸 Tallahassee, Florida, United States

National Hospital Organization Kinki-Chuo Chest Medical Center; 🇯🇵 Sakai-shi, Japan

Shizuoka Cancer Center; 🇯🇵 Shizuoka, Japan

Chonnam National University Hwasun Hospital; 🇰🇷 Jeollanam-do, Korea, Republic of

St. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of

AVIX Investigación Clínica S.C; 🇲🇽 Monterrey, Nuevo LEON, Mexico

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional; 🇵🇪 Lima, Peru

Main Military Clinical Hospital named after N.N. Burdenko; 🇷🇺 Moscow, Moskovskaja Oblast, Russian Federation

National Cheng Kung Uni Hospital; Dept of Hematology and Oncology; 🇨🇳 Tainan, Taiwan

Kangbuk Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii; 🇵🇱 Olsztyn, Poland

Peter Maccallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Rocky Mountain Cancer Center - Denver; 🇺🇸 Denver, Colorado, United States

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda; 🇧🇷 Ijui, Rio Grande Do Sul, Brazil

Hospital de Cancer de Barretos; 🇧🇷 Barretos, São Paulo, Brazil

SCRI Florida Cancer Specialists North; 🇺🇸 Saint Petersburg, Florida, United States

Klinik Penzing; 🇦🇹 Wien, Austria

Krankenhaus Nord - Klinik Floridsdorf; 🇦🇹 Wien, Austria

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China