Recruiting
Phase 3

Atezolizumab & Hyaluronidase

Sponsor:

National Cancer Institute (NCI)

Code:

NCT07388524

Conditions

Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atezolizumab

Atezolizumab and Recombinant Human Hyaluronidase

Biospecimen Collection

Computed Tomography

Patient Observation

Study Details

Brief summary:

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.

Conditions

Lung Non-Small Cell Carcinoma

Study ID

NCT07388524

Start date

Mar 2, 2027

Status verified date

Jun, 2026

Completion date

Sep 30, 2032

Anticipated

Primary completion date

Sep 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

336 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A (observation)

Patients undergo observation for 1 year. Patients also undergo CT and optional collection of blood samples throughout the trial.

experimental: Arm B (atezolizumab)

Patients receive atezolizumab IV over 60 minutes or atezolizumab and recombinant human hyaluronidase SC over 7 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year (17 cycles) in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and optional collection of blood samples throughout the trial.

Interventions

Atezolizumab

Given IV

Atezolizumab and Recombinant Human Hyaluronidase

Given SC

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo CT

Patient Observation

Undergo observation

Primary outcome measure

  • Disease-free survival [ Time Frame: From randomization to disease recurrence, second lung primary, or death, assessed up to 10 years ]

Central Contacts and Locations

Locations

Tower Cancer Research Foundation

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Site Public Contact

towercancerresearch@toweroncology.com

Principal Investigator:

Kamya Sankar

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Site Public Contact

310-423-2133Cancer.trial.info@cshs.org

Principal Investigator:

Kamya Sankar

Cedars-Sinai Cancer - Tarzana

Recruiting

Tarzana, California, United States, 91356

Contacts

Site Public Contact

818-981-3818

Principal Investigator:

Kamya Sankar

Torrance Memorial Physician Network - Cancer Care

Recruiting

Torrance, California, United States, 90505

Contacts

Site Public Contact

310-750-3300courtney.steeneken@tmphysicians.com

Principal Investigator:

Kamya Sankar

Beebe South Coastal Health Campus

Recruiting

Millville, Delaware, United States, 19967

Contacts

Site Public Contact

302-291-6730research@beebehealthcare.org

Principal Investigator:

Gregory A. Masters

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Beebe Health Campus

Recruiting

Rehoboth Beach, Delaware, United States, 19971

Contacts

Site Public Contact

302-291-6730research@beebehealthcare.org

Principal Investigator:

Gregory A. Masters

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Vamsi K. Vasireddy

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Vamsi K. Vasireddy

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Vamsi K. Vasireddy

Carle BroMenn Medical Center

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Vamsi K. Vasireddy

Carle Cancer Institute Normal

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Vamsi K. Vasireddy

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Site Public Contact

217-528-7541pallante.beth@mhsil.com

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Vamsi K. Vasireddy

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Mary Greeley Medical Center

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Ames

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-239-4734ksoder@mcfarlandclinic.com

Principal Investigator:

Joseph J. Merchant

Mercy Hospital

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-365-4673

Principal Investigator:

Deborah W. Wilbur

Oncology Associates at Mercy Medical Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-363-2690

Principal Investigator:

Deborah W. Wilbur

McFarland Clinic - Trinity Cancer Center

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Marshalltown

Recruiting

Marshalltown, Iowa, United States, 50158

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

Owensboro Health Mitchell Memorial Cancer Center

Recruiting

Owensboro, Kentucky, United States, 42303

Contacts

Site Public Contact

270-691-8094vanissa.sorrels@owensborohealth.org

Principal Investigator:

Jewraj G. Maheshwari

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Hematology Oncology Associates of CNY at Camillus

Recruiting

Camillus, New York, United States, 13031

Contacts

Site Public Contact

315-472-7504

Principal Investigator:

Steven M. Duffy

Hematology Oncology Associates of Central New York-East Syracuse

Recruiting

East Syracuse, New York, United States, 13057

Contacts

Site Public Contact

315-472-7504

Principal Investigator:

Steven M. Duffy

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Amna Sher

FirstHealth of the Carolinas-Moore Regional Hospital

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

Site Public Contact

910-715-3500jcwilliams@firsthealth.org

Principal Investigator:

Charles S. Kuzma

ProMedica Flower Hospital

Recruiting

Sylvania, Ohio, United States, 43560

Contacts

Site Public Contact

419-824-1842PCIOncResearch@promedica.org

Principal Investigator:

Ali Raufi

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Muhammad Furqan

ProHealth D N Greenwald Center

Recruiting

Mukwonago, Wisconsin, United States, 53149

Contacts

Site Public Contact

research.institute@phci.org

Principal Investigator:

Timothy R. Wassenaar

ProHealth Oconomowoc Memorial Hospital

Recruiting

Oconomowoc, Wisconsin, United States, 53066

Contacts

Site Public Contact

262-928-7878

Principal Investigator:

Timothy R. Wassenaar

ProHealth Waukesha Memorial Hospital

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Site Public Contact

262-928-7632

Principal Investigator:

Timothy R. Wassenaar

UW Cancer Center at ProHealth Care

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Site Public Contact

262-928-5539Chanda.miller@phci.org

Principal Investigator:

Timothy R. Wassenaar

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-03.