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

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

Trial Details

NCT ID
NCT07388524
Phase
PHASE3
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Atezolizumab
  • Atezolizumab and Recombinant Human Hyaluronidase
  • Biospecimen Collection
  • Computed Tomography
  • Patient Observation
Locations (sample)
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Tarzana, California, United States|34.17334,-118.55397
  • Millville, Delaware, United States|38.54956,-75.12324
  • Newark, Delaware, United States|39.68372,-75.74966
  • Coeur d'Alene, Idaho, United States|47.67768,-116.78047

Key Eligibility Criteria

  • Pathologically stage IA3 or IB NSCLC per American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 9th edition
  • Note: Tumors with any histology are allowed including both squamous and non-squamous subtypes, except those containing small-cell morphology. Non-s…
  • Patient must have undergone complete surgical resection with negative margins (complete R0 resection). Surgical resection must be lobectomy or high…
  • Note: For patients who underwent sub-lobar resection for clinical tumors size of ≤ 2.0 cm, must have CT chest confirming tumor size within 60 days …

For full eligibility, visit ClinicalTrials.gov.

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