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Could an immunotherapy drug keep early lung cancer from returning?

NCT ID NCT07388524

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 32 times

Summary

This phase III trial is testing whether the immunotherapy drug atezolizumab, given after surgery, can prevent stage I non-small cell lung cancer from returning. About 336 patients who have had their tumor completely removed will be randomly assigned to receive either atezolizumab (with or without hyaluronidase to aid absorption) or standard observation. The goal is to see if the drug improves disease-free survival compared to just watching and waiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Atezolizumab (an immunotherapy drug that helps the immune system attack cancer cells)
What this could lead to
If successful, this could offer a way to reduce the risk of lung cancer returning after surgery, potentially improving long-term outcomes for early-stage patients.
What could go wrong
This is an early-stage cancer trial, and immunotherapy can cause side effects like inflammation in healthy organs. The benefit over standard observation is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 336 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung non-small cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    70 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beebe Health Campus

    RECRUITING

    Rehoboth Beach, Delaware, 19971, United States

    Contact Email: •••••@•••••

  • Beebe South Coastal Health Campus

    RECRUITING

    Millville, Delaware, 19967, United States

    Contact Email: •••••@•••••

  • Benefis Sletten Cancer Institute

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Billings Clinic Cancer Center

    RECRUITING

    Billings, Montana, 59101, United States

    Contact Email: •••••@•••••

  • Bozeman Health Deaconess Hospital

    RECRUITING

    Bozeman, Montana, 59715, United States

    Contact Email: •••••@•••••

  • Cancer Care Center of O'Fallon

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Cancer Care Specialists of Illinois - Decatur

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Carle BroMenn Medical Center

    RECRUITING

    Normal, Illinois, 61761, United States

    Contact Email: •••••@•••••

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Cancer Institute Normal

    RECRUITING

    Normal, Illinois, 61761, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Cedars-Sinai Cancer - Tarzana

    RECRUITING

    Tarzana, California, 91356, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Community Medical Center

    RECRUITING

    Missoula, Montana, 59804, United States

    Contact Email: •••••@•••••

  • Decatur Memorial Hospital

    RECRUITING

    Decatur, Illinois, 62526, United States

  • FirstHealth of the Carolinas-Moore Regional Hospital

    RECRUITING

    Pinehurst, North Carolina, 28374, United States

  • HSHS Saint Elizabeth's Hospital

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Helen F Graham Cancer Center

    RECRUITING

    Newark, Delaware, 19713, United States

  • Hematology Oncology Associates of CNY at Camillus

    RECRUITING

    Camillus, New York, 13031, United States

  • Hematology Oncology Associates of Central New York-East Syracuse

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Illinois CancerCare - Washington

    RECRUITING

    Washington, Illinois, 61571, United States

  • Illinois CancerCare-Bloomington

    RECRUITING

    Bloomington, Illinois, 61704, United States

  • Illinois CancerCare-Canton

    RECRUITING

    Canton, Illinois, 61520, United States

  • Illinois CancerCare-Carthage

    RECRUITING

    Carthage, Illinois, 62321, United States

  • Illinois CancerCare-Eureka

    RECRUITING

    Eureka, Illinois, 61530, United States

  • Illinois CancerCare-Galesburg

    RECRUITING

    Galesburg, Illinois, 61401, United States

  • Illinois CancerCare-Kewanee Clinic

    RECRUITING

    Kewanee, Illinois, 61443, United States

  • Illinois CancerCare-Macomb

    RECRUITING

    Macomb, Illinois, 61455, United States

  • Illinois CancerCare-Ottawa Clinic

    RECRUITING

    Ottawa, Illinois, 61350, United States

  • Illinois CancerCare-Pekin

    RECRUITING

    Pekin, Illinois, 61554, United States

  • Illinois CancerCare-Peoria

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Illinois CancerCare-Peru

    RECRUITING

    Peru, Illinois, 61354, United States

  • Illinois CancerCare-Princeton

    RECRUITING

    Princeton, Illinois, 61356, United States

  • Jersey Shore Medical Center

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Kootenai Clinic Cancer Services - Post Falls

    RECRUITING

    Post Falls, Idaho, 83854, United States

    Contact Email: •••••@•••••

  • Kootenai Clinic Cancer Services - Sandpoint

    RECRUITING

    Sandpoint, Idaho, 83864, United States

    Contact Email: •••••@•••••

  • Kootenai Health - Coeur d'Alene

    RECRUITING

    Coeur d'Alene, Idaho, 83814, United States

    Contact Email: •••••@•••••

  • Mary Greeley Medical Center

    RECRUITING

    Ames, Iowa, 50010, United States

  • McFarland Clinic - Ames

    RECRUITING

    Ames, Iowa, 50010, United States

  • McFarland Clinic - Marshalltown

    RECRUITING

    Marshalltown, Iowa, 50158, United States

  • McFarland Clinic - Trinity Cancer Center

    RECRUITING

    Fort Dodge, Iowa, 50501, United States

  • Medical Oncology Hematology Consultants PA

    RECRUITING

    Newark, Delaware, 19713, United States

  • Mercy Hospital

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Northwest Cancer Center - Crown Point

    RECRUITING

    Crown Point, Indiana, 46307, United States

    Contact Email: •••••@•••••

  • Northwest Cancer Center - Valparaiso

    RECRUITING

    Valparaiso, Indiana, 46383, United States

    Contact Email: •••••@•••••

  • Northwest Oncology LLC

    RECRUITING

    Dyer, Indiana, 46311, United States

  • Ocean University Medical Center

    RECRUITING

    Brick, New Jersey, 08724, United States

  • Oncology Associates at Mercy Medical Center

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Owensboro Health Mitchell Memorial Cancer Center

    RECRUITING

    Owensboro, Kentucky, 42303, United States

  • ProHealth D N Greenwald Center

    RECRUITING

    Mukwonago, Wisconsin, 53149, United States

  • ProHealth Oconomowoc Memorial Hospital

    RECRUITING

    Oconomowoc, Wisconsin, 53066, United States

  • ProHealth Waukesha Memorial Hospital

    RECRUITING

    Waukesha, Wisconsin, 53188, United States

  • ProMedica Flower Hospital

    RECRUITING

    Sylvania, Ohio, 43560, United States

    Contact Email: •••••@•••••

  • Riverview Medical Center/Booker Cancer Center

    RECRUITING

    Red Bank, New Jersey, 07701, United States

  • Saint Catherine Hospital

    RECRUITING

    Indianapolis, Indiana, 46312, United States

  • Saint Francis Medical Center

    RECRUITING

    Cape Girardeau, Missouri, 63703, United States

  • Saint Mary Medical Center

    RECRUITING

    Hobart, Indiana, 46342, United States

    Contact Email: •••••@•••••

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Southern Ocean County Medical Center

    RECRUITING

    Manahawkin, New Jersey, 08050, United States

  • Springfield Clinic

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Springfield Memorial Hospital

    RECRUITING

    Springfield, Illinois, 62781, United States

  • Stony Brook University Medical Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • The Community Hospital

    RECRUITING

    Munster, Indiana, 46321, United States

  • Torrance Memorial Physician Network - Cancer Care

    RECRUITING

    Torrance, California, 90505, United States

  • Tower Cancer Research Foundation

    RECRUITING

    Beverly Hills, California, 90211, United States

    Contact Email: •••••@•••••

  • UW Cancer Center at ProHealth Care

    RECRUITING

    Waukesha, Wisconsin, 53188, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Women's Diagnostic Center - Munster

    RECRUITING

    Munster, Indiana, 46321, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.