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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
Sponsor: National Cancer Institute (NCI)
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2027-03-02
Completion Date
2032-09-30
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
Atezolizumab
Given IV
Atezolizumab and Recombinant Human Hyaluronidase
Given SC
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Patient Observation
Undergo observation
Locations (59)
Tower Cancer Research Foundation
Beverly Hills, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Cedars-Sinai Cancer - Tarzana
Tarzana, California, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Carle BroMenn Medical Center
Normal, Illinois, United States
Carle Cancer Institute Normal
Normal, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic - Ames
Ames, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Community Medical Center
Missoula, Montana, United States
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States