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A clinical trial to compare tiragolumab plus atezolizumab with placebo plus atezolizumab in people with untreated advanced non-small cell lung cancer
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
- Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Cities
- 's-Hertogenbosch
- Aalborg
- Adana
- alicante--alacant-
- Ankara
- Arequipa
- Athens
- Avellino
- Badalona
- Barcelona
- bei-jing-shi
- Beograd
- Bern
- Budapest
- Campania
- cascina-perseghetto
- chang-chun-shi
- chang-zhou-shi
- Cheng Du Shi
- cheongju
- chong-qing-shi
- Chuo City
- Ciudad de México
- Den Haag
- Dnipro
- Ede
- Fairfax
- Frankfurt am Main
- Fukuoka
- Fuzhou
- Gdańsk
- Gerlingen
- Großhansdorf
- guang-zhou-shi
- Gyöngyös
- hai-kou-shi
- Halle (Saale)
- hang-zhou-shi
- Harbin
- Heidelberg
- Hwasun
- Immenhausen
- Ina
- Incheon
- İstanbul
- Ivano-Frankivs'k
- İzmir
- Ji Nan Shi
- Kaohsiung
- Kaohsiung City
- Kashiwa
- Koto City
- Krung Thep Maha Nakhon
- Kryvyi Rih
- København
- Larissa
- Leeuwarden
- Lima
- Linz
- Littleton
- Lombardia
- Löwenstein
- Madrid
- Majadahonda
- Malatya
- mei-zhou-shi
- Melbourne
- Monterrey
- Monza
- Moscow Oblast
- Moskva
- Málaga
- Münster
- Nagaizumi
- Nagoya
- nan-tong-shi
- Nanchang
- Nashville
- New Haven
- New Taipei City
- Niigata
- Novosibirsk
- Olsztyn
- Osaka
- Osakasayama
- Otwock
- Padova
- Perugia
- Pireas
- Poznań
- prilly
- Rio Grande do Sul
- Roma
- Roskilde
- Saint Paul
- Saint Petersburg
- Sakai
- Salem
- San Isidro
- Sanatorio San Luigi
- Sankt-Peterburg
- Santiago de Querétaro
- Sendai
- Seongnam-si
- Seoul
- Sevilla
- shang-hai-shi
- Shanghai
- Sremska Kamenica
- St. Gallen
- St. Petersburg
- Surquillo
- Suwon
- Suwon-si
- Szolnok
- São Paulo
- Taichung City
- Tainan City
- Taipei City
- Tallahassee
- tambon-kho-hong
- Taoyuan City
- tian-jin-shi
- Uzhhorod
- Vancouver
- Wien
- Woolloongabba
- wu-han-shi
- xi-an-shi
- xia-men-shi
- Yaroslavl
- Zaragoza
Trial Identifier:
NCT04294810 2022-502482-17-00 GO41717
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04294810, GO41717, 2022-502482-17-00
Trial Identifier
Atezolizumab, Tiragolumab, Matching Placebo
Treatments
Non-Small Cell Lung Cancer
Condition
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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.
For the latest version of this information please go to www.forpatients.roche.com