Clinical trial NCT04294810: 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
Official title: A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
timeFrame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
measure: Overall Survival (OS) in the Primary Analysis Set
timeFrame: From randomization to death from any cause (up to approximately 59 months)
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 59 months
measure: Percentage of Participants With Cytokine-Release Syndrome (CRS)
timeFrame: Up to approximately 59 months
Secondary outcomes:
measure: Investigator-Assessed PFS in the Secondary Analysis Set
timeFrame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
measure: OS in the Secondary Analysis Set
timeFrame: From randomization to death from any cause (up to approximately 59 months)
measure: Investigator-Assessed Confirmed Objective Response Rate (ORR)
timeFrame: From randomization up to approximately 59 months
measure: Investigator-Assessed Duration of Response (DOR)
timeFrame: 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)
measure: Investigator-Assessed PFS Rates at 6 Months and 12 Months
timeFrame: 6 months, 12 months
measure: OS Rates at 12 Months and 24 Months
timeFrame: 12 months, 24 months
measure: Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
timeFrame: From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Center - Denver
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Saint Petersburg
country: United States
facility: SCRI Florida Cancer Specialists North
state: Florida
city: Tallahassee
country: United States
facility: SCRI Florida Cancer Specialists PAN
state: Florida
city: Saint Paul
country: United States
facility: US oncology research at Minnesota Oncology
state: Minnesota
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Fairfax
country: United States
facility: Virginia Cancer Specialists (Fairfax) - USOR
state: Virginia
city: Salem
country: United States
facility: Onc & Hem Assoc SW Virginia
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists - Vancouver
state: Washington
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Hospital Olivia Newton John Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
city: Wien
country: Austria
facility: Klinik Penzing
city: Wien
country: Austria
facility: Krankenhaus Nord - Klinik Floridsdorf
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: São Paulo
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Haikou
country: China
facility: Hainan General Hospital
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan City
country: China
facility: Jinan Central Hospital
city: Meizhou City
country: China
facility: Meizhou People's Hospital
city: Nanchang City
country: China
facility: The 1st Affiliated Hospital of Nanchang Unversity
city: Nantong City
country: China
facility: Nantong Tumor Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Wuhan City
country: China
facility: Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf GmbH
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH
city: Loewenstein
country: Germany
facility: SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Stuttgart
country: Germany
facility: Klinik Schillerhöhe
city: Athens
country: Greece
facility: Sotiria Hospital
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Diavalkaniko Hospital
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet
city: Matrahaza
country: Hungary
facility: Matrai Gyogyintezet
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
state: Campania
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Roma
country: Italy
facility: Policlinico Universitario "Agostino Gemelli"
state: Lazio
city: Milano
country: Italy
facility: Irccs Istituto Europeo di Oncologia (IEO)
state: Lombardia
city: Monza
country: Italy
facility: Asst Di Monza
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga
state: Piemonte
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
state: Umbria
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS
state: Veneto
city: Aichi
country: Japan
facility: Aichi Cancer Center
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Sakai-shi
country: Japan
facility: NHO Kinki-Chuo Chest Medical Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
city: CD Mexico
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Mexico
country: Mexico
facility: Cryptex Investigacion Clinica SA de CV
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: AVIX Investigación Clínica S.C
state: Nuevo LEON
city: Querétaro
country: Mexico
facility: Cuidados oncologicos
state: Queretaro
city: 'S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis, locatie Leyweg
city: EDE
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Arequipa
country: Peru
facility: Instituto Regional de Enfermedades Neoplásicas del Sur
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Olsztyn
country: Poland
facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
city: Moscow
country: Russian Federation
facility: Main Military Clinical Hospital named after N.N. Burdenko
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: MEDSI Clinical Hospital on Pyatnitsky Highway
state: Moskovskaja Oblast
city: St Petersburg
country: Russian Federation
facility: Institute of Oncology
state: Sankt Petersburg
city: St Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
state: Sankt Petersburg
city: St Petersburg
country: Russian Federation
facility: St. Petersburg Med Univ
state: Sankt Petersburg
city: ST Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
state: Sankt Petersburg
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Bezanijska kosa
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Madrid
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Zaragoza
country: Spain
facility: Hosp Clinico Univ Lozano Blesa
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Lausanne
country: Switzerland
facility: CHUV
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen Medizin Onkologie
city: Guishan Dist.
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University ?Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung Uni Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Zhongzheng Dist.
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Adana
country: Turkey
facility: Adana Baskent University Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Faculty of Medicine
city: Izmir
country: Turkey
facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
city: Kadiköy
country: Turkey
facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty of Medicine
city: Seyhan
country: Turkey
facility: Medical Park Seyhan Hospital
city: Dnipropetrovsk
country: Ukraine
facility: City Clinical Hospital #4
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Oncology Center
city: Kryvyi Rih
country: Ukraine
facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
city: Uzhgorod
country: Ukraine
facility: Uzhgorod Nat. University Central Municip Hosp
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trial
role: STUDY_DIRECTOR
References: