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
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 620
- 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.
- 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
- 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. 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. 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.
- 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 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 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) 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 (141)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Inselspital Bern
🇨🇭Bern, Switzerland
CHUV
🇨🇭Lausanne, Switzerland
Kantonsspital St.Gallen Medizin Onkologie
🇨🇭St. Gallen, Switzerland
Chang Gung Memorial Hospital - Linkou Branch
🇨🇳Guishan Dist., Taiwan
Ivano-Frankivsk Regional Oncology Center
🇺🇦Ivano-Frankivsk, Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
🇺🇦Kryvyi Rih, Ukraine
Uzhgorod Nat. University Central Municip Hosp
🇺🇦Uzhgorod, Ukraine
Klinik Penzing
🇦🇹Wien, Austria
Krankenhaus Nord - Klinik Floridsdorf
🇦🇹Wien, Austria
University Hospital of Larissa
🇬🇷Larissa, Greece
Diavalkaniko Hospital
🇬🇷Thessaloniki, Greece
Orszagos Koranyi TBC es Pulmonologiai Intezet
🇭🇺Budapest, Hungary
Matrai Gyogyintezet
🇭🇺Matrahaza, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház
🇭🇺Szolnok, Hungary
Songklanagarind Hospital
🇹🇭Songkhla, Thailand
Adana Baskent University Hospital
🇹🇷Adana, Turkey
Azienda Ospedaliera San Giuseppe Moscati
🇮🇹Avellino, Campania, Italy
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Austin Hospital Olivia Newton John Cancer Centre
🇦🇺Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Ordensklinikum Linz Elisabethinen
🇦🇹Linz, Austria
Rocky Mountain Cancer Center - Denver
🇺🇸Denver, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
SCRI Florida Cancer Specialists North
🇺🇸Saint Petersburg, Florida, United States
SCRI Florida Cancer Specialists PAN
🇺🇸Tallahassee, Florida, United States
US oncology research at Minnesota Oncology
🇺🇸Saint Paul, Minnesota, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Virginia Cancer Specialists (Fairfax) - USOR
🇺🇸Fairfax, Virginia, United States
Onc & Hem Assoc SW Virginia
🇺🇸Salem, Virginia, United States
Northwest Cancer Specialists - Vancouver
🇺🇸Vancouver, Washington, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Hospital de Cancer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Beijing Cancer Hospital
🇨🇳Beijing, China
The First Hospital of Jilin University
🇨🇳Changchun City, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Chongqing Cancer Hospital
🇨🇳Chongqing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, 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 City, China
Nantong Tumor Hospital
🇨🇳Nantong City, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, 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, China
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
LungenClinic Großhansdorf GmbH
🇩🇪Großhansdorf, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
🇩🇪Halle (Saale), Germany
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
🇩🇪Loewenstein, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
🇩🇪Münster, Germany
Klinik Schillerhöhe
🇩🇪Stuttgart, Germany
Sotiria Hospital
🇬🇷Athens, Greece
Metropolitan Hospital
🇬🇷Athens, Greece
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
🇮🇹Napoli, Campania, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Lazio, Italy
Policlinico Universitario "Agostino Gemelli"
🇮🇹Roma, Lazio, Italy
Irccs Istituto Europeo di Oncologia (IEO)
🇮🇹Milano, Lombardia, Italy
Asst Di Monza
🇮🇹Monza, Lombardia, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Lombardia, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
🇮🇹Orbassano, Piemonte, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
🇮🇹Perugia, Umbria, Italy
IOV - Istituto Oncologico Veneto - IRCCS
🇮🇹Padova, Veneto, Italy
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
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Kindai University Hospital
🇯🇵Osaka, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
NHO 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, Japan
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, 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 Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Health Pharma Professional Research
🇲🇽CD Mexico, 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, Mexico
Jeroen Bosch Ziekenhuis
🇳🇱'S Hertogenbosch, Netherlands
Hagaziekenhuis, locatie Leyweg
🇳🇱Den Haag, Netherlands
Ziekenhuis Gelderse Vallei
🇳🇱EDE, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Instituto Regional de Enfermedades Neoplásicas del Sur
🇵🇪Arequipa, Peru
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Clinica Internacional, Sede San Borja
🇵🇪Lima, Peru
Clinica Ricardo Palma
🇵🇪San Isidro, Peru
Uniwersyteckie Centrum Kliniczne
🇵🇱Gda?sk, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
🇵🇱Olsztyn, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
🇵🇱Otwock, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
🇵🇱Poznan, Poland
Main Military Clinical Hospital named after N.N. Burdenko
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
Institute of Oncology
🇷🇺St Petersburg, Sankt Petersburg, Russian Federation
Leningrad Regional Clinical Hospital
🇷🇺St Petersburg, Sankt Petersburg, Russian Federation
St. Petersburg Med Univ
🇷🇺St Petersburg, Sankt Petersburg, Russian Federation
St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
🇷🇺ST Petersburg, Sankt Petersburg, Russian Federation
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
University Hospital Medical Center Bezanijska kosa
🇷🇸Belgrade, Serbia
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hosp Clinico Univ Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Medical University ?Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung Uni Hospital
🇨🇳Tainan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Zhongzheng Dist., Taiwan
Chulalongkorn Hospital
🇹🇭Bangkok, Thailand
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Faculty of Med. Siriraj Hosp.
🇹🇭Bangkok, Thailand
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
🇹🇷Kadiköy, Turkey
Inonu University Medical Faculty of Medicine
🇹🇷Malatya, Turkey
Medical Park Seyhan Hospital
🇹🇷Seyhan, Turkey
City Clinical Hospital #4
🇺🇦Dnipropetrovsk, Ukraine