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NCT07388524From ClinicalTrials.govRecruiting

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.

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Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell L | Trialion