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New hope for lung cancer patients: drug may keep cancer at bay after standard treatment

NCT ID NCT07559786

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Updated 2 times

Summary

This study tests whether a drug called adebrelimab can help keep limited-stage small cell lung cancer from coming back after initial chemotherapy and radiation. About 200 adults aged 18-75 with untreated, limited-stage disease will be randomly assigned to receive either standard treatment alone or standard treatment followed by adebrelimab maintenance therapy. The main goal is to see if adebrelimab extends the time without cancer progression.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 75 years

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: 1.Age ≥ 18 and ≤ 75 years, regardless of gender. 2.Histopathologically confirmed, untreated limited-stage small cell lung cancer (LS-SCLC) (stage I-III per AJCC 8th edition, with all lesions encompassed in a tolerable radiation plan). 3.Clinically staged T1-2N0, operable LS-SCLC patients who are ineligible for surgery or refuse surgery. 4.ECOG performance status 0-1. 5.Expected survival ≥ 3 months. 6.At least one measurable lesion per RECIST 1.1. 7.Pulmonary function: FEV1 \> 70% of predicted value. 8.Adequate hematologic and end-organ function, with laboratory results obtained within 7 days before first study treatment: 1. Hematology: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without G-CSF support within 14 days before first treatment; lymphocyte count (LC) ≥ 0.5×10⁹/L; platelet count (PLT) ≥ 90×10⁹/L without transfusion, G-CSF, or other hematopoietic stimulants within 14 days before first treatment. 2. Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN (≤3.0 mg/dL for patients with confirmed Gilbert syndrome). 3. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min (calculated by Cockcroft-Gault, CKD-EPI, or MDRD equation); urine protein \< 2+ (if urine protein ≥ 2+, 24-hour urine protein must be \< 1 g for eligibility). 4. Coagulation: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. 5. Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%. 9.Sexually active subjects of reproductive potential (non-sterilized) must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after treatment completion. For females of reproductive potential: serum pregnancy test (HCG) must be negative within 7 days before first dosing. 10.Subjects are voluntarily enrolled, provide written informed consent, have good compliance, and agree to follow-up. Exclusion Criteria: 1. Histologically confirmed combined small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC). 2. Prior systemic anti-tumor therapy or immune checkpoint inhibitor therapy for SCLC. 3. Extensive-stage SCLC. 4. Presence of malignant pleural effusion. If aspiratable pleural effusion is present during screening, at least one thoracentesis must be performed to confirm the presence or absence of malignant cells. 5. Subjects with known or suspected interstitial lung disease (ILD); other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, etc. 6. History of active, known or suspected autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. (Exceptions: Type 1 diabetes mellitus (glycemic control with insulin); residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; conditions not expected to relapse in the absence of external trigger. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo only (excluding psoriatic arthritis) may be enrolled if: rash involves \<10% of body surface area; disease is well controlled at baseline with only low-potency topical steroids; and no acute exacerbation in the past 12 months (no PUVA, methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids).) 7. Concomitant malignancy diagnosed ≤3 years before first study treatment, except adequately treated papillary thyroid carcinoma, cervical carcinoma in situ, basal or squamous cell skin cancer, locally controlled prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery (hormonal therapy for non-metastatic prostate or breast cancer is allowed). 8. History of clinically significant cardiovascular disease, including but not limited to: Congestive heart failure (NYHA class \>2); Unstable angina; Myocardial infarction within 3 months before signing ICF; Any severe supraventricular or ventricular arrhythmia requiring treatment or intervention. 9. Severe infection within 4 weeks before first treatment, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; active infection of CTCAE grade ≥2 requiring systemic antibiotics within 2 weeks before first treatment. 10. Active tuberculosis within 1 year before enrollment by history or CT scan, or history of active tuberculosis \>1 year ago without standard treatment. 11. History of immunodeficiency, including positive HIV serology. 12. Active hepatitis B or hepatitis C.(HBsAg-positive or HBcAb-positive subjects may be enrolled if HBV DNA \< upper limit of normal (ULN) of the local laboratory (if no ULN, HBV DNA \<1000 copies/mL or 500 IU/mL); HCV Ab-positive subjects may be enrolled if HCV RNA \< ULN of the local laboratory (if no ULN, HCV RNA \<500 IU/mL).) 13. Receipt of systemic immunosuppressive therapy within 14 days before first treatment, including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents. (1)Patients receiving short-term systemic immunosuppression (e.g., corticosteroids for management/prophylaxis of nausea, vomiting, or hypersensitivity) may be enrolled at the investigator's discretion; a washout period before randomization may be required. (2)Allowed: inhaled corticosteroids for COPD; mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension; low-dose corticosteroid replacement (≤10 mg/day prednisone or equivalent) for adrenal insufficiency. 14.Major surgery within 28 days before first treatment (except diagnostic surgery), or expected major surgery during the study (except diagnostic surgery). 15.Administration of live attenuated vaccine within 28 days before first treatment, or anticipated need during the study (live attenuated influenza vaccine is prohibited within 28 days before first treatment, during treatment, and for 5 months after the last dose of adebrelimab). 16.Prior allogeneic bone marrow transplant or solid organ transplant. 17.History of severe hypersensitivity to monoclonal antibody/fusion protein drugs. 18.Known psychiatric disorder, alcoholism, drug abuse or substance abuse. 19.Any other condition that, in the investigator's judgment, may prematurely terminate the study, e.g., poor protocol compliance, other severe diseases requiring concurrent treatment, significant laboratory abnormalities, or family/social factors affecting subject safety or data/sample collection.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Henan Cancer Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

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