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NCT07388524 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 336
- Enrollment target
NCT07388524: Recruiting Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT07388524 is a Phase 3 study that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 336 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07388524, a Phase 3 study, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 336 participants
- Enrollment target
Study 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.
Primary Outcome
Distributions of survival time between treatment arms will be compared with a one-sided stratified log-rank test. The rates at various timepoints and medians for each arm will be estimated using the Kaplan-Meier estimator. The 95% confidence interval will be calculated using Greenwood's formula and based on a log-log transformation applied to the survival function. Hazard ratios will be estimated using a stratified Cox regression model. Multivariable Cox models will be used to evaluate the treat
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Atezolizumab
- OTHER Patient Observation
- BIOLOGICAL Atezolizumab and Recombinant Human Hyaluronidase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2027-03-02 |
| Est. Completion | 2032-09-30 |
| Phase | Phase 3 |
What NCT07388524 shows while recruiting
NCT07388524 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07388524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07388524 about?
NCT07388524 is a clinical study titled "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 ...
What is the current status of trial NCT07388524?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 336 participants. The study started on 2027-03-02. Estimated completion is 2032-09-30.
What interventions are being tested in trial NCT07388524?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (BIOLOGICAL), Patient Observation (OTHER), Atezolizumab and Recombinant Human Hyaluronidase (BIOLOGICAL).
Who is sponsoring clinical trial NCT07388524?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07388524's enrollment target sits among peer trials
336 1060th of 2000 higher than 940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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