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NCT07388524RecruitingPhase 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

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)

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
336 (estimated)
First submitted
4 Feb 2026
Start date
2 Mar 2027
Primary completion date
30 Sept 2032
Lead sponsor
National Cancer Institute (NCI)
Diseases
Lung cancer
NCT number
NCT07388524

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 336
  • From 2 Mar 2027 to the primary completion date, 30 Sept 2032
  • 133 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (133)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mary Greeley Medical Center
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AmesUnited StatesRecruiting
McFarland Clinic - Ames
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AmesUnited StatesRecruiting
Community Hospital of Anaconda
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AnacondaUnited StatesRecruiting
Duluth Clinic Ashland
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AshlandUnited StatesRecruiting
Bronson Battle Creek
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Battle CreekUnited StatesRecruiting
Northwell Health Imbert Cancer Center
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Bay ShoreUnited StatesRecruiting
Kaiser Permanente-Bellflower
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BellflowerUnited StatesRecruiting
Tower Cancer Research Foundation
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Beverly HillsUnited StatesRecruiting
Billings Clinic Cancer Center
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BillingsUnited StatesRecruiting
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesRecruiting
Bozeman Health Deaconess Hospital
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BozemanUnited StatesRecruiting
Essentia Health Saint Joseph's Medical Center
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BrainerdUnited StatesRecruiting
Ocean University Medical Center
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BrickUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
Hematology Oncology Associates of CNY at Camillus
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CamillusUnited StatesRecruiting
Illinois CancerCare-Canton
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CantonUnited StatesRecruiting
Saint Francis Medical Center
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Cape GirardeauUnited StatesRecruiting
Illinois CancerCare-Carthage
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CarthageUnited StatesRecruiting
Mercy Hospital
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Cedar RapidsUnited StatesRecruiting
Physicians' Clinic of Iowa PC
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Cedar RapidsUnited StatesRecruiting
Oncology Associates at Mercy Medical Center
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Cedar RapidsUnited StatesRecruiting
John H Stroger Jr Hospital of Cook County
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ChicagoUnited StatesRecruiting
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesRecruiting
Mercy Hospital
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Coon RapidsUnited StatesRecruiting
Northwest Cancer Center - Crown Point
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Crown PointUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Decatur Memorial Hospital
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DecaturUnited StatesRecruiting
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesRecruiting
Essentia Health - Deer River Clinic
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Deer RiverUnited StatesRecruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
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Detroit LakesUnited StatesRecruiting
Essentia Health Cancer Center
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DuluthUnited StatesRecruiting
Northwest Oncology LLC
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DyerUnited StatesRecruiting
Hematology Oncology Associates of Central New York-East Syracuse
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East SyracuseUnited StatesRecruiting
Fairview Southdale Hospital
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EdinaUnited StatesRecruiting
Minnesota Oncology - Edina
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EdinaUnited StatesRecruiting
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Illinois CancerCare-Eureka
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EurekaUnited StatesRecruiting
University of Kansas Clinical Research Center
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FairwayUnited StatesRecruiting
Essentia Health Cancer Center-South University Clinic
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FargoUnited StatesRecruiting
McFarland Clinic - Trinity Cancer Center
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Fort DodgeUnited StatesRecruiting
Illinois CancerCare-Galesburg
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GalesburgUnited StatesRecruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesRecruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesRecruiting
Benefis Sletten Cancer Institute
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Great FallsUnited StatesRecruiting
Bellin Memorial Hospital
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Green BayUnited StatesRecruiting
Northwell Health Cancer Institute at Huntington
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GreenlawnUnited StatesRecruiting
Kaiser Permanente South Bay
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Harbor CityUnited StatesRecruiting
Essentia Health Hibbing Clinic
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HibbingUnited StatesRecruiting
Saint Mary Medical Center
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HobartUnited StatesRecruiting
Saint Catherine Hospital
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IndianapolisUnited StatesRecruiting
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesRecruiting
West Michigan Cancer Center
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KalamazooUnited StatesRecruiting
Bronson Methodist Hospital
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KalamazooUnited StatesRecruiting
Logan Health Medical Center
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KalispellUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - Briarcliff
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - North
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Kansas CityUnited StatesRecruiting
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesRecruiting
Northwell Health/Center for Advanced Medicine
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Lake SuccessUnited StatesRecruiting
University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesRecruiting
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesRecruiting
Liberty Hospital
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LibertyUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Illinois CancerCare-Macomb
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MacombUnited StatesRecruiting
Southern Ocean County Medical Center
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ManahawkinUnited StatesRecruiting
McFarland Clinic - Marshalltown
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MarshalltownUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Beebe South Coastal Health Campus
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MillvilleUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Abbott-Northwestern Hospital
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MinneapolisUnited StatesRecruiting
Community Medical Center
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MissoulaUnited StatesRecruiting
Northern Westchester Hospital
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Mount KiscoUnited StatesRecruiting
ProHealth D N Greenwald Center
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MukwonagoUnited StatesRecruiting
The Community Hospital
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MunsterUnited StatesRecruiting
Women's Diagnostic Center - Munster
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MunsterUnited StatesRecruiting
Jersey Shore Medical Center
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Neptune CityUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
Helen F Graham Cancer Center
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NewarkUnited StatesRecruiting
Froedtert and MCW Moorland Reserve Health Center
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New BerlinUnited StatesRecruiting
Lenox Hill Hospital
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New YorkUnited StatesRecruiting
Manhattan Eye Ear and Throat Hospital
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New YorkUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Niles Hospital
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NilesUnited StatesRecruiting
Carle Cancer Institute Normal
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NormalUnited StatesRecruiting
Carle BroMenn Medical Center
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NormalUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
ProHealth Oconomowoc Memorial Hospital
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OconomowocUnited StatesRecruiting
HSHS Saint Elizabeth's Hospital
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O'FallonUnited StatesRecruiting
Cancer Care Center of O'Fallon
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O'FallonUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
The University of Kansas Cancer Center - Olathe
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OlatheUnited StatesRecruiting
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesRecruiting
University of Kansas Hospital-Indian Creek Campus
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Overland ParkUnited StatesRecruiting
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesRecruiting
Owensboro Health Mitchell Memorial Cancer Center
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OwensboroUnited StatesRecruiting
Illinois CancerCare-Pekin
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PekinUnited StatesRecruiting
Illinois CancerCare-Peoria
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PeoriaUnited StatesRecruiting
Illinois CancerCare-Peru
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PeruUnited StatesRecruiting
FirstHealth of the Carolinas-Moore Regional Hospital
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PinehurstUnited StatesRecruiting
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesRecruiting
Illinois CancerCare-Princeton
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PrincetonUnited StatesRecruiting
Riverview Medical Center/Booker Cancer Center
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Red BankUnited StatesRecruiting
Corewell Health Reed City Hospital
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Reed CityUnited StatesRecruiting
Queens Cancer Center
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Rego ParkUnited StatesRecruiting
Beebe Health Campus
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Rehoboth BeachUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Saint JosephUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint JosephUnited StatesRecruiting
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesRecruiting
United Hospital
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Saint PaulUnited StatesRecruiting
Regions Hospital
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Saint PaulUnited StatesRecruiting
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesRecruiting
Essentia Health Sandstone
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SandstoneUnited StatesRecruiting
Swedish Medical Center-First Hill
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SeattleUnited StatesRecruiting
Phelps Memorial Hospital Center
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Sleepy HollowUnited StatesRecruiting
Springfield Memorial Hospital
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SpringfieldUnited StatesRecruiting
Springfield Clinic
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SpringfieldUnited StatesRecruiting
Southern Illinois University School of Medicine
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SpringfieldUnited StatesRecruiting
Stony Brook University Medical Center
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Stony BrookUnited StatesRecruiting
Essentia Health Saint Mary's Hospital - Superior
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SuperiorUnited StatesRecruiting
ProMedica Flower Hospital
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SylvaniaUnited StatesRecruiting
Cedars-Sinai Cancer - Tarzana
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TarzanaUnited StatesRecruiting
Torrance Memorial Physician Network - Cancer Care
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TorranceUnited StatesRecruiting
Munson Medical Center
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Traverse CityUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Northwest Cancer Center - Valparaiso
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ValparaisoUnited StatesRecruiting
Essentia Health Virginia Clinic
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VirginiaUnited StatesRecruiting
Illinois CancerCare - Washington
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WashingtonUnited StatesRecruiting
UW Cancer Center at ProHealth Care
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WaukeshaUnited StatesRecruiting
ProHealth Waukesha Memorial Hospital
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WaukeshaUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
University of Michigan Health - West
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WyomingUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.