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

Status
Closed
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04513925
Protocol IDs
GO41854 (primary)
NCI-2020-07791
2019-004773-29
Study Sponsor
Hoffmann-La Roche

Summary

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.

Eligibility

  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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.