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

Conditions

• Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Feb 5, 2026

Start date

Mar 2, 2027

Status verified

Jun 2026

Primary completion

Sep 30, 2032

Completion

Sep 30, 2032

Study Design

Enrollment

336 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (observation)
  Patients undergo observation for 1 year. Patients also undergo CT and optional collection of blood samples throughout the trial.
• Experimental: Arm B (atezolizumab)
  Patients receive atezolizumab IV over 60 minutes or atezolizumab and recombinant human hyaluronidase 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.

Primary Outcome Measure

Disease-free survival [ Time Frame: From randomization to disease recurrence, second lung primary, or death, assessed up to 10 years ]

Locations (18)

Find similar trials in Newark, DE

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