A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Completed · Phase 3

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.

Key facts

Study ID: NCT04513925
Run by: Hoffmann-La Roche
People needed: 829
Starts: 2020-08-24
Expected to finish: 2025-07-31
Last updated by the study team: 2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
No progression during or following concurrent platinum-based CRT
A known PD-L1 result
Life expectancy >/= 12 weeks
Adequate hematologic and end-organ function
Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab

You may not qualify if…

Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
Any evidence of Stage IV disease
Treatment with sequential CRT for locally advanced NSCLC
Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
Any Grade >2 unresolved toxicity from previous CRT
Grade >= 2 pneumonitis from prior CRT
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
History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
Prior allogeneic stem cell or solid organ transplantation
Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
Treatment with systemic immunosuppressive medication
Women who are pregnant, or breastfeeding

Where it is running

Banner MD Anderson Cancer Center — Greeley, Colorado, United States
Florida Cancer Specialists — Fort Myers, Florida, United States
Cancer Care Centers of Brevard — Palm Bay, Florida, United States
Woodlands Medical Specialists, P.A. — Pensacola, Florida, United States
Florida Cancer Specialist, North Region — St. Petersburg, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
Illinois Cancer Care — Peoria, Illinois, United States
New England Cancer Specialists — Brunswick, Maine, United States
Southcoast Health System — Fairhaven, Massachusetts, United States
Minnesota Oncology Hematology — Minneapolis, Minnesota, United States
HCA Midwest Health — Kansas City, Missouri, United States
Cox Health Systems — Springfield, Missouri, United States
Optum Health Care — Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
Titan Health Partners LLC, d/b/a Astera Cancer Care — East Brunswick, New Jersey, United States
San Juan Oncology Associates — Farmington, New Mexico, United States
New York Oncology Hematology,P.C.-Albany — Albany, New York, United States
Mount Sinai Medical Center — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Prisma Health ? Upstate — Greenville, South Carolina, United States
Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
Sarah Cannon Research Institute / Tennessee Oncology — Nashville, Tennessee, United States
Virginia Cancer Specialists — Fairfax, Virginia, United States
Virginia Oncology Associates — Norfolk, Virginia, United States
Stanford University — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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