A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT03563716
Last Updated: 2026-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2018-08-10
2025-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo + Atezolizumab
Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
Placebo
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Tiragolumab + Atezolizumab
Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
Tiragolumab
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Interventions
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Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
Tiragolumab
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Placebo
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented locally advanced unresectable NSCLC, recurrent, or metastatic NSCLC of either squamous or non-squamous histology
* No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
* Tumor PD-L1 expression
* Measurable disease, as defined by RECIST v1.1
* Life expectancy \>=12 weeks
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria
* Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to screening
* History of leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome
General Medical Exclusions:
* Pregnant and lactating women
* Significant cardiovascular disease
* Severe infections within 4 weeks prior to randomization
* Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
Treatment-Specific Exclusions:
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
* History of autoimmune disease
* Prior allogeneic bone marrow transplantation or solid organ transplantation
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
* Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or active tuberculosis
* Administration of a live, attenuated vaccine within 4 weeks prior to randomization
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arizona Oncology Associates, PC - HAL
Tempe, Arizona, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Research Medical Center
Kansas City, Missouri, United States
SCRI Tennessee Oncology
Nashville, Tennessee, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States
ICO Paul Papin
Angers, , France
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, , France
Centre Georges François Leclerc
Dijon, , France
Hopital Nord AP-HM
Marseille, , France
Institut De Cancerologie De L'Ouest
Saint-Herblain, , France
Institute of Lung Diseases Vojvodina
Kamenitz, Južnobanatski Okrug, Serbia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Chungbuk National University Hospital
Cheongju-si, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Univ Germans Trias i Pujol
Badalona, Barcelona, Spain
Complejo Hospitalario Universitario Insular?Materno Infantil
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Clinica Universitaria Navarra (Madrid)
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, , Spain
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, , Spain
Centro Medico Quironsalud Sagrado Corazon
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Taipei Medical University ?Shuang Ho Hospital
New Taipei City, , Taiwan
National Cheng Kung University Hospital
North Dist., , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan District, , Taiwan
Countries
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References
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Guan X, Hu R, Choi Y, Srivats S, Nabet BY, Silva J, McGinnis L, Hendricks R, Nutsch K, Banta KL, Duong E, Dunkle A, Chang PS, Han CJ, Mittman S, Molden N, Daggumati P, Connolly W, Johnson M, Abreu DR, Cho BC, Italiano A, Gil-Bazo I, Felip E, Mellman I, Mariathasan S, Shames DS, Meng R, Chiang EY, Johnston RJ, Patil NS. Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells. Nature. 2024 Mar;627(8004):646-655. doi: 10.1038/s41586-024-07121-9. Epub 2024 Feb 28.
Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-000280-81
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508083-30-00
Identifier Type: CTIS
Identifier Source: secondary_id
GO40290
Identifier Type: -
Identifier Source: org_study_id
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