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
Sites (133)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mary Greeley Medical Center Coordinator of this site? Confirm its status | Ames | United States | Recruiting |
| McFarland Clinic - Ames Coordinator of this site? Confirm its status | Ames | United States | Recruiting |
| Community Hospital of Anaconda Coordinator of this site? Confirm its status | Anaconda | United States | Recruiting |
| Duluth Clinic Ashland Coordinator of this site? Confirm its status | Ashland | United States | Recruiting |
| Bronson Battle Creek Coordinator of this site? Confirm its status | Battle Creek | United States | Recruiting |
| Northwell Health Imbert Cancer Center Coordinator of this site? Confirm its status | Bay Shore | United States | Recruiting |
| Kaiser Permanente-Bellflower Coordinator of this site? Confirm its status | Bellflower | United States | Recruiting |
| Tower Cancer Research Foundation Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| Billings Clinic Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Recruiting |
| Illinois CancerCare-Bloomington Coordinator of this site? Confirm its status | Bloomington | United States | Recruiting |
| Bozeman Health Deaconess Hospital Coordinator of this site? Confirm its status | Bozeman | United States | Recruiting |
| Essentia Health Saint Joseph's Medical Center Coordinator of this site? Confirm its status | Brainerd | United States | Recruiting |
| Ocean University Medical Center Coordinator of this site? Confirm its status | Brick | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Hematology Oncology Associates of CNY at Camillus Coordinator of this site? Confirm its status | Camillus | United States | Recruiting |
| Illinois CancerCare-Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Saint Francis Medical Center Coordinator of this site? Confirm its status | Cape Girardeau | United States | Recruiting |
| Illinois CancerCare-Carthage Coordinator of this site? Confirm its status | Carthage | United States | Recruiting |
| Mercy Hospital Coordinator of this site? Confirm its status | Cedar Rapids | United States | Recruiting |
| Physicians' Clinic of Iowa PC Coordinator of this site? Confirm its status | Cedar Rapids | United States | Recruiting |
| Oncology Associates at Mercy Medical Center Coordinator of this site? Confirm its status | Cedar Rapids | United States | Recruiting |
| John H Stroger Jr Hospital of Cook County Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Kootenai Health - Coeur d'Alene Coordinator of this site? Confirm its status | Coeur d'Alene | United States | Recruiting |
| Mercy Hospital Coordinator of this site? Confirm its status | Coon Rapids | United States | Recruiting |
| Northwest Cancer Center - Crown Point Coordinator of this site? Confirm its status | Crown Point | United States | Recruiting |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Essentia Health - Deer River Clinic Coordinator of this site? Confirm its status | Deer River | United States | Recruiting |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Coordinator of this site? Confirm its status | Detroit Lakes | United States | Recruiting |
| Essentia Health Cancer Center Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Northwest Oncology LLC Coordinator of this site? Confirm its status | Dyer | United States | Recruiting |
| Hematology Oncology Associates of Central New York-East Syracuse Coordinator of this site? Confirm its status | East Syracuse | United States | Recruiting |
| Fairview Southdale Hospital Coordinator of this site? Confirm its status | Edina | United States | Recruiting |
| Minnesota Oncology - Edina Coordinator of this site? Confirm its status | Edina | United States | Recruiting |
| Swedish Cancer Institute-Edmonds Coordinator of this site? Confirm its status | Edmonds | United States | Recruiting |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Recruiting |
| Illinois CancerCare-Eureka Coordinator of this site? Confirm its status | Eureka | United States | Recruiting |
| University of Kansas Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Recruiting |
| Essentia Health Cancer Center-South University Clinic Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| McFarland Clinic - Trinity Cancer Center Coordinator of this site? Confirm its status | Fort Dodge | United States | Recruiting |
| Illinois CancerCare-Galesburg Coordinator of this site? Confirm its status | Galesburg | United States | Recruiting |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Benefis Sletten Cancer Institute Coordinator of this site? Confirm its status | Great Falls | United States | Recruiting |
| Bellin Memorial Hospital Coordinator of this site? Confirm its status | Green Bay | United States | Recruiting |
| Northwell Health Cancer Institute at Huntington Coordinator of this site? Confirm its status | Greenlawn | United States | Recruiting |
| Kaiser Permanente South Bay Coordinator of this site? Confirm its status | Harbor City | United States | Recruiting |
| Essentia Health Hibbing Clinic Coordinator of this site? Confirm its status | Hibbing | United States | Recruiting |
| Saint Mary Medical Center Coordinator of this site? Confirm its status | Hobart | United States | Recruiting |
| Saint Catherine Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Swedish Cancer Institute-Issaquah Coordinator of this site? Confirm its status | Issaquah | United States | Recruiting |
| West Michigan Cancer Center Coordinator of this site? Confirm its status | Kalamazoo | United States | Recruiting |
| Bronson Methodist Hospital Coordinator of this site? Confirm its status | Kalamazoo | United States | Recruiting |
| Logan Health Medical Center Coordinator of this site? Confirm its status | Kalispell | United States | Recruiting |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Kansas Cancer Center - Briarcliff Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Kansas Cancer Center - North Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Illinois CancerCare-Kewanee Clinic Coordinator of this site? Confirm its status | Kewanee | United States | Recruiting |
| Northwell Health/Center for Advanced Medicine Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| University of Kansas Cancer Center - Lee's Summit Coordinator of this site? Confirm its status | Lee's Summit | United States | Recruiting |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Liberty Hospital Coordinator of this site? Confirm its status | Liberty | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Illinois CancerCare-Macomb Coordinator of this site? Confirm its status | Macomb | United States | Recruiting |
| Southern Ocean County Medical Center Coordinator of this site? Confirm its status | Manahawkin | United States | Recruiting |
| McFarland Clinic - Marshalltown Coordinator of this site? Confirm its status | Marshalltown | United States | Recruiting |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Recruiting |
| Froedtert Menomonee Falls Hospital Coordinator of this site? Confirm its status | Menomonee Falls | United States | Recruiting |
| Beebe South Coastal Health Campus Coordinator of this site? Confirm its status | Millville | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Abbott-Northwestern Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Community Medical Center Coordinator of this site? Confirm its status | Missoula | United States | Recruiting |
| Northern Westchester Hospital Coordinator of this site? Confirm its status | Mount Kisco | United States | Recruiting |
| ProHealth D N Greenwald Center Coordinator of this site? Confirm its status | Mukwonago | United States | Recruiting |
| The Community Hospital Coordinator of this site? Confirm its status | Munster | United States | Recruiting |
| Women's Diagnostic Center - Munster Coordinator of this site? Confirm its status | Munster | United States | Recruiting |
| Jersey Shore Medical Center Coordinator of this site? Confirm its status | Neptune City | United States | Recruiting |
| Medical Oncology Hematology Consultants PA Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center Coordinator of this site? Confirm its status | New Berlin | United States | Recruiting |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Manhattan Eye Ear and Throat Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Corewell Health Lakeland Hospitals - Niles Hospital Coordinator of this site? Confirm its status | Niles | United States | Recruiting |
| Carle Cancer Institute Normal Coordinator of this site? Confirm its status | Normal | United States | Recruiting |
| Carle BroMenn Medical Center Coordinator of this site? Confirm its status | Normal | United States | Recruiting |
| Drexel Town Square Health Center Coordinator of this site? Confirm its status | Oak Creek | United States | Recruiting |
| ProHealth Oconomowoc Memorial Hospital Coordinator of this site? Confirm its status | Oconomowoc | United States | Recruiting |
| HSHS Saint Elizabeth's Hospital Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| Cancer Care Center of O'Fallon Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| The University of Kansas Cancer Center - Olathe Coordinator of this site? Confirm its status | Olathe | United States | Recruiting |
| Illinois CancerCare-Ottawa Clinic Coordinator of this site? Confirm its status | Ottawa | United States | Recruiting |
| University of Kansas Hospital-Indian Creek Campus Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| University of Kansas Cancer Center-Overland Park Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Owensboro Health Mitchell Memorial Cancer Center Coordinator of this site? Confirm its status | Owensboro | United States | Recruiting |
| Illinois CancerCare-Pekin Coordinator of this site? Confirm its status | Pekin | United States | Recruiting |
| Illinois CancerCare-Peoria Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Illinois CancerCare-Peru Coordinator of this site? Confirm its status | Peru | United States | Recruiting |
| FirstHealth of the Carolinas-Moore Regional Hospital Coordinator of this site? Confirm its status | Pinehurst | United States | Recruiting |
| Kootenai Clinic Cancer Services - Post Falls Coordinator of this site? Confirm its status | Post Falls | United States | Recruiting |
| Illinois CancerCare-Princeton Coordinator of this site? Confirm its status | Princeton | United States | Recruiting |
| Riverview Medical Center/Booker Cancer Center Coordinator of this site? Confirm its status | Red Bank | United States | Recruiting |
| Corewell Health Reed City Hospital Coordinator of this site? Confirm its status | Reed City | United States | Recruiting |
| Queens Cancer Center Coordinator of this site? Confirm its status | Rego Park | United States | Recruiting |
| Beebe Health Campus Coordinator of this site? Confirm its status | Rehoboth Beach | United States | Recruiting |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Coordinator of this site? Confirm its status | Saint Joseph | United States | Recruiting |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Coordinator of this site? Confirm its status | Saint Joseph | United States | Recruiting |
| Park Nicollet Clinic - Saint Louis Park Coordinator of this site? Confirm its status | Saint Louis Park | United States | Recruiting |
| United Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
| Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
| Kootenai Clinic Cancer Services - Sandpoint Coordinator of this site? Confirm its status | Sandpoint | United States | Recruiting |
| Essentia Health Sandstone Coordinator of this site? Confirm its status | Sandstone | United States | Recruiting |
| Swedish Medical Center-First Hill Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Phelps Memorial Hospital Center Coordinator of this site? Confirm its status | Sleepy Hollow | United States | Recruiting |
| Springfield Memorial Hospital Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
| Essentia Health Saint Mary's Hospital - Superior Coordinator of this site? Confirm its status | Superior | United States | Recruiting |
| ProMedica Flower Hospital Coordinator of this site? Confirm its status | Sylvania | United States | Recruiting |
| Cedars-Sinai Cancer - Tarzana Coordinator of this site? Confirm its status | Tarzana | United States | Recruiting |
| Torrance Memorial Physician Network - Cancer Care Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
| Munson Medical Center Coordinator of this site? Confirm its status | Traverse City | United States | Recruiting |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Recruiting |
| Northwest Cancer Center - Valparaiso Coordinator of this site? Confirm its status | Valparaiso | United States | Recruiting |
| Essentia Health Virginia Clinic Coordinator of this site? Confirm its status | Virginia | United States | Recruiting |
| Illinois CancerCare - Washington Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
| UW Cancer Center at ProHealth Care Coordinator of this site? Confirm its status | Waukesha | United States | Recruiting |
| ProHealth Waukesha Memorial Hospital Coordinator of this site? Confirm its status | Waukesha | United States | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center Coordinator of this site? Confirm its status | West Bend | United States | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
| University of Michigan Health - West Coordinator of this site? Confirm its status | Wyoming | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.