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)
- Lung Non-Small Cell Carcinoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- National Cancer Institute (NCI)
- Enrolment target
- 336
- Started
- 2 March 2027
- Main results due
- 30 September 2032
- Study sites
- 72
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(72)
Tower Cancer Research Foundation
Beverly Hills, California, United States
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Recruiting
Cedars-Sinai Cancer - Tarzana
Tarzana, California, United States
Recruiting
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, United States
Recruiting
Helen F Graham Cancer Center
Newark, Delaware, United States
Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Recruiting
Illinois CancerCare-Canton
Canton, Illinois, United States
Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Recruiting
Carle at The Riverfront
Danville, Illinois, United States
Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Recruiting
Decatur Memorial Hospital
Decatur, Illinois, United States
Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, United States
Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Recruiting
Carle BroMenn Medical Center
Normal, Illinois, United States
Recruiting
Carle Cancer Institute Normal
Normal, Illinois, United States
Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States
Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Recruiting
Illinois CancerCare-Peru
Peru, Illinois, United States
Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Recruiting
Springfield Clinic
Springfield, Illinois, United States
Recruiting
Springfield Memorial Hospital
Springfield, Illinois, United States
Recruiting
Carle Cancer Center
Urbana, Illinois, United States
Recruiting
Illinois CancerCare - Washington
Washington, Illinois, United States
Recruiting
Northwest Cancer Center - Crown Point
Crown Point, Indiana, United States
Recruiting
Northwest Oncology LLC
Dyer, Indiana, United States
Recruiting
Saint Mary Medical Center
Hobart, Indiana, United States
Recruiting
Saint Catherine Hospital
Indianapolis, Indiana, United States
Recruiting
The Community Hospital
Munster, Indiana, United States
Recruiting
Women's Diagnostic Center - Munster
Munster, Indiana, United States
Recruiting
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, United States
Recruiting
Mary Greeley Medical Center
Ames, Iowa, United States
Recruiting
McFarland Clinic - Ames
Ames, Iowa, United States
Recruiting
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Recruiting
Mercy Hospital
Cedar Rapids, Iowa, United States
Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States
Recruiting
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States
Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Recruiting
Billings Clinic Cancer Center
Billings, Montana, United States
Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Recruiting
Community Medical Center
Missoula, Montana, United States
Recruiting
Ocean University Medical Center
Brick, New Jersey, United States
Recruiting
Southern Ocean County Medical Center
Manahawkin, New Jersey, United States
Recruiting
Jersey Shore Medical Center
Neptune City, New Jersey, United States
Recruiting
Showing 60 of 72 sites — filter to narrow it down. 72 of the 72 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07388524. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me