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
Start Date
3/2/2027
Completion Date
9/30/2032
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Atezolizumab
Atezolizumab and Recombinant Human Hyaluronidase
Biospecimen Collection
Computed Tomography
Patient Observation
Conditions
Locations
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United States
Illinois CancerCare-Peoria
Peoria, Illinois 61615
United States
Illinois CancerCare-Peru
Peru, Illinois 61354
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Mary Greeley Medical Center
Ames, Iowa 50010
United States
McFarland Clinic - Ames
Ames, Iowa 50010
United States
Mercy Hospital
Cedar Rapids, Iowa 52403
United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
United States
Community Medical Center
Missoula, Montana 59804
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States