Atezolizumab after surgery to prevent NSCLC from coming back
Official title: 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)
Run by National Cancer Institute (NCI) · NCT07388524 · Data updated 2026-11-12
This trial tests whether giving atezolizumab (with or without hyaluronidase) for one year after complete surgery helps prevent NSCLC from returning compared with observation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 336 (estimated) |
| Sponsor | National Cancer Institute (NCI) NIH |
| Drugs / interventions | atezolizumab, prednisone, Immunotherapy |
| Locations | 145 sites (Anaheim, California and 144 other locations) |
| Status | Recruiting |
| Started | March 2, 2027 |
| Main results expected | September 30, 2032 |
| Study ends | September 30, 2032 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07388524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with pathologically confirmed stage IA3–IB NSCLC who have had a complete resection (R0) with clear margins, including those undergoing lobectomy or sub-lobar resection under specific tumor size criteria.
✕Probably not a fit
Patients with contraindications to immunotherapy or those whose cancer recurs during or before starting therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 trial enrolls adults with stage IA3–IB non-small cell lung cancer who have had a complete surgical resection. Participants are randomized to receive either one year of atezolizumab (with or without recombinant hyaluronidase) or standard observation, with regular imaging and safety monitoring. The primary goal is to see if disease-free survival improves, while secondary goals include overall survival, recurrence-free survival, lung-cancer-specific survival, patterns of recurrence, and safety. Treatments are administered in cycles every 3 weeks for up to 17 cycles, and both groups undergo planned CT scans and specimen collection as feasible. The study is sponsored by the National Cancer Institute with participation from Kaiser Permanente sites in California.
Why it matters
Potential benefit: If successful, the approach could reduce the chances of lung cancer returning after surgery and improve survival for eligible patients.
How similar studies have gone: Immunotherapy after surgical resection has shown promise in other cancers and NSCLC settings, but this specific combination and regimen after early-stage NSCLC resection is being evaluated for benefit.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Kaiser Permanente-Anaheim
Anaheim, California, United States Recruiting -
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States Recruiting -
Kaiser Permanente-Bellflower
Bellflower, California, United States Recruiting -
Tower Cancer Research Foundation
Beverly Hills, California, United States Recruiting -
Kaiser Permanente-Fontana
Fontana, California, United States Recruiting -
Kaiser Permanente South Bay
Harbor City, California, United States Recruiting
Show 44 more locations
-
Kaiser Permanente-Irvine
Irvine, California, United States Recruiting -
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States Recruiting -
Kaiser Permanente West Los Angeles
Los Angeles, California, United States Recruiting -
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
Kaiser Permanente-Ontario
Ontario, California, United States Recruiting -
Kaiser Permanente - Panorama City
Panorama City, California, United States Recruiting -
Kaiser Permanente-Riverside
Riverside, California, United States Recruiting -
Kaiser Permanente-San Diego Zion
San Diego, California, United States Recruiting -
Kaiser Permanente-San Marcos
San Marcos, California, United States Recruiting -
Cedars-Sinai Cancer - Tarzana
Tarzana, California, United States Recruiting -
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States Recruiting -
Kaiser Permanente-Woodland Hills
Woodland Hills, 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 -
John H Stroger Jr Hospital of Cook County
Chicago, 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
+95 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Muhammad Furqan — Alliance for Clinical Trials in Oncology
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Blood biomarkers to predict response to atezolizumab plus bevacizumab in hepatocellular carcinoma
This study tests whether blood-based biomarkers can predict which patients with advanced liver cancer will respond to first-line atezolizumab plus bevacizumab.
-
BL-M14D1 with Atezolizumab for extensive-stage small cell lung cancer
This phase 2 trial tests whether adding BL-M14D1 to atezolizumab helps people with extensive-stage small cell lung cancer live longer or well enough to continue treatment.
-
BL-M14D1 plus atezolizumab vs standard therapy in first-line extensive-stage small cell lung cancer
A first-line treatment for adults with extensive-stage small cell lung cancer tests whether adding BL-M14D1 to atezolizumab and standard chemotherapy helps more than standard care.
-
DSP-0390 with Atezolizumab in extensive-stage small cell lung cancer
This pilot phase Ib study tests whether adding DSP-0390 to maintenance atezolizumab after initial chemo-immunotherapy is safe and shows early signs of activity in people with extensive-stage small cell lung cancer who have not progressed.
-
YSCH-01 alone or with atezolizumab for recurrent glioblastoma
This will test whether YSCH-01 by itself or together with atezolizumab helps people with recurrent glioblastoma live longer.
-
AI system to predict response to Atezolizumab-Bevacizumab in unresectable liver cancer
This study looks at whether an artificial intelligence tool can predict how patients with unresectable hepatocellular carcinoma will respond to atezolizumab-bevacizumab.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.