For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  2. Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
  3. Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
  4. 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)
  5. 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
  6. No progression during or following concurrent platinum-based CRT
  7. A known PD-L1 result
  8. Life expectancy >/= 12 weeks
  9. Adequate hematologic and end-organ function
  10. 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
  11. Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
  12. Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
  2. NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
  3. Any evidence of Stage IV disease
  4. Treatment with sequential CRT for locally advanced NSCLC
  5. Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
  6. Any Grade >2 unresolved toxicity from previous CRT
  7. Grade >= 2 pneumonitis from prior CRT
  8. Active or history of autoimmune disease or immune deficiency
  9. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis
  10. 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
  11. Prior allogeneic stem cell or solid organ transplantation
  12. Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
  13. Treatment with investigational therapy within 28 days prior to initiation of study treatment
  14. 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
  15. 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
  16. Treatment with systemic immunosuppressive medication
  17. Women who are pregnant, or breastfeeding

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Non-small Cell Lung Cancer (NSCLC)

Age (in years)

18+

Phase

Phase 3

Participants needed

829

Est. Completion Date

Dec 30, 2027

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT04513925

Study number

GO41854

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