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RECRUITING
NCT07388524
PHASE3

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)

View on ClinicalTrials.gov

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

Interventions

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

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