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RECRUITING Phase 3 ClinicalTrials.gov

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) • ClinicalTrials.gov ID: NCT07388524

Registry updated: 2026-10-20
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Description

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.

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

Eligibility criteria

Inclusion Criteria: * Pathologically stage IA3 or IB NSCLC per American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 9th edition * Note: Tumors with any histology are allowed including both squamous and non-squamous subtypes, except those containing small-cell morphology. Non-squamous histology includes adenocarcinoma, large cell neuroendocrine, poorly differentiated tumors and adenosquamous, etc * Patient must have undergone complete surgical resection with negative margins (complete R0 resection). Surgical resection must be lobectomy or higher, unless the tumor measured no more than 2 cm based on clinical staging, where sub-lobar resection, e.g., wedge or segmentectomy, will be acceptable * Note: For patients who underwent sub-lobar resection for clinical tumors size of ≤ 2.0 cm, must have CT chest confirming tumor size within 60 days of surgical resection. Patients who received a lobectomy or higher do not require to fulfill this imaging criteria * Patient must have undergone adequate nodal sampling as defined by Commission on Cancer, 2020 Standard. Adequate nodal sampling includes pathological evaluation of at least one (named and/or numbered) hilar station (level 10 or higher) and at least three distinct (named and or numbered) mediastinal stations (level 2-9) * PD-L1 immunohistochemistry showing tumor proportion score (TPS) ≥ 50%, by an Food and Drug Administration (FDA)-approved assay including but not limited to SP263, SP142, 22C3, 28-8, performed either on surgical specimen or biopsy specimen * No EGFR exon 19 deletion (del) or L858R mutation or ALK fusion; molecular testing may have been performed either on surgical specimen or biopsy specimen. Tumors with purely squamous histology are not required to undergo EGFR or ALK gene testing * Patient to be registered to A082302 no earlier than 21 days and no later than 77 days from surgical resection * Recovered from surgical resection as determined by the treating provider or the investigator * No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis * Patient must NOT have uncontrolled intercurrent illness, including but not limited to serious ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class ≥ III), unstable angina, or unstable arrhythmia * No current pneumonitis or history of (non-infectious) pneumonitis that required steroids or history of interstitial lung disease (ILD) * No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease modifying agents, corticosteroids, or immunomodulatory agents). Replacement therapy (e.g., thyroid for history of autoimmune thyroiditis, insulin for type I or II diabetes, corticosteroids for adrenal or pituitary insufficiency) is not considered a form of systemic treatment * No known hypersensitivity (≥ grade 3) to atezolizumab and/or any of its excipients * No live vaccine within 30 days prior to registration. Examples include but are not limited to: measles, mumps, rubella, varicella, yellow fever, Bacillus Calmette-Guerin (BCG), typhoid, nasally administered influenza * No history of prior allogeneic bone marrow, stem cell, or solid organ transplant * Patient has not received continuous systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days prior to registration, with the following exceptions: * Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, if \< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen or chronic obstructive pulmonary disease \[COPD\] exacerbation) is permitted * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%) * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 1.5 x upper limit of normal (ULN), except patients with Gilbert syndrome who can have total bilirubin \< 3.0 mg/dl * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN) * Creatinine clearance ≥ 30 mL/min (using standard Cockcroft-Gault formula, unless measured creatinine clearance \[CrCl\] is available and meet the specified threshold) * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. Patients with no known history of HIV do not require any testing * Hepatitis B and hepatitis C: No active hepatitis B (defined as negative for hepatitis B \[HepB\] deoxyribonucleic acid \[DNA\], and positive for HepB surface antibody) or hepatitis C (defined as hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] detected) infection. If there is a history of either infection, patient should be negative for active disease, for hepatitis B negative for hepatitis B virus surface antigen (HBsAg), and for hepatitis C - negative for HCV RNA (qualitative). Patients with no known history of chronic hepatitis do not require any testing * No active infection requiring systemic therapy * Cardiac function: Patients with known history or current symptoms of heart failure, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better

Conditions

Lung Non-Small Cell Carcinoma

Locations

  • 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
  • Northwest Cancer Center - Crown Point — Crown Point, Indiana, United States
  • Northwest Oncology LLC — Dyer, Indiana, United States
  • Saint Mary Medical Center — Hobart, Indiana, United States
  • Saint Catherine Hospital — Indianapolis, Indiana, United States
  • The Community Hospital — Munster, Indiana, United States
  • Women's Diagnostic Center - Munster — Munster, Indiana, United States
  • Northwest Cancer Center - Valparaiso — Valparaiso, Indiana, United States
  • Mary Greeley Medical Center — Ames, Iowa, United States
  • McFarland Clinic - Ames — Ames, Iowa, United States
  • Physicians' Clinic of Iowa PC — Cedar Rapids, 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
  • Bronson Battle Creek — Battle Creek, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
  • Bronson Methodist Hospital — Kalamazoo, Michigan, United States
  • West Michigan Cancer Center — Kalamazoo, Michigan, United States
  • Corewell Health Lakeland Hospitals - Niles Hospital — Niles, Michigan, United States
  • Corewell Health Reed City Hospital — Reed City, Michigan, United States
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center — Saint Joseph, Michigan, United States
  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital — Saint Joseph, Michigan, United States
  • Munson Medical Center — Traverse City, Michigan, United States
  • University of Michigan Health - West — Wyoming, Michigan, United States
  • Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
  • Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
  • Essentia Health Saint Mary's - Detroit Lakes Clinic — Detroit Lakes, Minnesota, United States
  • Essentia Health Cancer Center — Duluth, Minnesota, United States
  • Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
  • Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
  • United Hospital — Saint Paul, Minnesota, United States
  • Essentia Health Sandstone — Sandstone, Minnesota, United States
  • Essentia Health Virginia Clinic — Virginia, Minnesota, 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
  • Logan Health Medical Center — Kalispell, Montana, United States
  • Community Medical Center — Missoula, Montana, United States
  • Ocean University Medical Center — Brick, New Jersey, United States
  • Southern Ocean County Medical Center — Manahawkin, New Jersey, United States
  • Jersey Shore Medical Center — Neptune City, New Jersey, United States
  • Riverview Medical Center/Booker Cancer Center — Red Bank, New Jersey, United States
  • Roswell Park Cancer Institute — Buffalo, New York, 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
  • Essentia Health Cancer Center-South University Clinic — Fargo, North Dakota, United States
  • ProMedica Flower Hospital — Sylvania, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Swedish Cancer Institute-Edmonds — Edmonds, Washington, United States
  • Swedish Cancer Institute-Issaquah — Issaquah, Washington, United States
  • Swedish Medical Center-First Hill — Seattle, Washington, United States
  • Duluth Clinic Ashland — Ashland, Wisconsin, United States
  • Bellin Memorial Hospital — Green Bay, Wisconsin, United States
  • Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • ProHealth D N Greenwald Center — Mukwonago, Wisconsin, United States
  • Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
  • Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
  • ProHealth Oconomowoc Memorial Hospital — Oconomowoc, Wisconsin, United States
  • Essentia Health Saint Mary's Hospital - Superior — Superior, Wisconsin, United States
  • ProHealth Waukesha Memorial Hospital — Waukesha, Wisconsin, United States
  • UW Cancer Center at ProHealth Care — Waukesha, Wisconsin, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record