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Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 76 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Study sites: 96 to 97
  2. Minor Trial sites expanded: 83 → 96 locations Trial sites expanded: 72 → 83 locations Show 1 more changeShow less
    • Trial sites expanded: 72 → 83 locations
  3. Minor Study sites: 72 to 83
  4. Minor Study sites: 70 to 72
  5. Minor Trial sites expanded: 63 → 70 locations Secondary endpoints: details revised at 6 of 6 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 6 of 6 entries
  6. Minor Trial sites expanded: 59 → 63 locationsv71
  7. Minor Site details revised at 4 of 59 sitesv70
  8. Minor Site details revised at 4 of 59 sitesv69
  9. Minor Trial sites expanded: 55 → 59 locationsv68
  10. Minor Trial sites expanded: 51 → 55 locationsv67
  11. Minor Trial sites expanded: 44 → 49 locationsv66
  12. Minor Trial sites expanded: 36 → 43 locationsv65
  13. Minor Study sites: 43 to 44v64
  14. Minor Study sites: 36 to 43v63
  15. Minor Study sites: 34 to 36v62
  16. Minor Study sites: 33 to 34v61
  17. Minor Trial sites expanded: 25 → 33 locationsv60
  18. Minor Trial sites expanded: 20 → 25 locationsv59
  19. Minor Trial sites expanded: 15 → 18 locationsv58
  20. Minor Study sites: 15 to 18v57
  21. Minor Study sites: 14 to 15v56
  22. Minor Study sites: 13 to 14v55
  23. Minor Study sites: 11 to 13v54
  24. Minor Study sites: 10 to 11v53
  25. Minor Trial sites expanded: 5 → 10 locations Trial sites expanded: 2 → 5 locationsv52 Show 1 more changeShow less
    • Trial sites expanded: 2 → 5 locations
  26. Minor Study sites: 2 to 5v51
  27. Minor Study sites: 3 to 2v50
  28. Minor Study sites: 1 to 3v49
  29. Notable Primary and study completion pushed from Sep 30, 2029 to Sep 30, 2032 Recruitment opened · Start date: Jun 5, 2026 to Mar 2, 2027 · Study sites: 0 to 1v48 Show 3 more changesShow less
    • Recruitment opened
    • Start date: Jun 5, 2026 to Mar 2, 2027
    • Study sites: 0 to 1
  30. Minor Re-verified, no change to tracked fieldsv47
  31. Notable Start date: Apr 9, 2026 to Jun 5, 2026v46
  32. Minor 19 versions Re-verified since Mar 13, 2026, no change to tracked fieldsv27-v45
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation or active surveillance, which involves closely watching a patient's condition but not giving treatment unless there are changes in test results. During active surveillance, patients are given certain exams and tests done on a regular schedule. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Atezolizumab and recombinant human hyaluronidase is a formulation of atezolizumab combined with an enzyme called hyaluronidase, which helps increase tissue absorption of the drug. Giving atezolizumab or atezolizumab and recombinant human hyaluronidase after resection may be effective for preventing NSCLC recurrence, and may be a better approach to treating patients with stage I NSCLC than the usual observation approach.
Trial Details
NCT Number NCT07388524
Lead Sponsor National Cancer Institute (NCI)
Conditions Lung Non-Small Cell Carcinoma
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov