NCT07388524

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

Evaluating Adjuvant Atezolizumab or Atezolizumab and Hyaluronidase-TQJS to Prevent Recurrence in Stage I Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase III Trial (AASI-NSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To compare disease-free survival (DFS) in the intent-to-treat patient population, among patients randomized to receive atezolizumab for one year (Arm B) versus (vs.) observation (Arm A). SECONDARY OBJECTIVES: I. To compare overall survival (OS) between patients randomized to atezolizumab versus observation. II. To compare recurrence-free survival (RFS) between patients randomized to atezolizumab versus observation. III. To compare lung-cancer-specific OS between patients randomized to atezolizumab versus observation. IV. To compare rates of loco-regional recurrences between patients randomized to atezolizumab versus observation. V. To compare rates of distant recurrences between patients randomized to atezolizumab versus observation. VI. To compare adverse event rates (AEs) via Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 between patients randomized to atezolizumab versus observation. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo observation for 1 year. Patients also undergo computed tomography (CT) and optional collection of blood samples throughout the trial. ARM B: Patients receive atezolizumab intravenously (IV) over 60 minutes or atezolizumab and recombinant human hyaluronidase subcutaneously (SC) over 7 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year (17 cycles) in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and optional collection of blood samples throughout the trial. After completion of study treatment, patients are followed up at 30 days (patients in Arm B only), then every 6 months for 3 years and then annually thereafter for an additional 7 years (10 years total).

Conditions

• Lung Non-Small Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Atezolizumab	Given IV
BIOLOGICAL	Atezolizumab and Recombinant Human Hyaluronidase	Given SC
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Computed Tomography	Undergo CT
OTHER	Patient Observation	Undergo observation

Timeline

• Start date: 2026-06-05
• Primary completion: 2029-09-30
• Completion: 2029-09-30
• First posted: 2026-02-05
• Last updated: 2026-04-17

Regulatory

• FDA-regulated drug study