A Multicenter, Randomized, Cohort, Prospective Clinical Study of Adebrelimab Consolidation Therapy for Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Without Progression After Concurrent Chemoradiotherapy

This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. This study plans to enroll patients with untreated limited-stage small cell lung cancer who meet the inclusion criteria. The eligible patients will be randomly divided 1:1 into two groups to receive treatment regimens for residual lymph nodes and involved irradiated areas. That is, carboplatin AUC 5, D1 + etoposide 100 mg/m…^2 on days 1, 2, and 3 + thoracic radiotherapy (residual lymph nodes or involved irradiated areas), with each 3-week cycle.After 4 cycles of concurrent chemoradiotherapy, the non-progressing subjects will continue to receive adebrelimab (1200 mg, IV, Q3W) maintenance therapy.

Study Overview

• Status: Not yet recruiting
• Conditions: SCLC, Limited Stage
• Intervention / Treatment: Drug: Involved-Field Radiotherapy (IFRT) group; Drug: Nodal residual-field radiotherapy group

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qingminf QM Wang, Professor; Phone Number: +8613783590691; Email: qimingwang1006@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
      • Contact: QiMing QM Wang, Professor; Phone Number: +8613783590691; Email: qimingwang1006@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 3 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nodal involved-field radiotherapy group; Carboplatin + Etoposide plus thoracic involved-field radiotherapy (IFRT), followed by maintenance therapy with adebrelimab in patients without progressive disease (non-PD)	Drug: Involved-Field Radiotherapy (IFRT) group; Carboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic involved-field radiotherapy (IFRT), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w.
Experimental: Lymph node residual field group; Carboplatin + Etoposide plus thoracic residual-field radiotherapy (for nodal residual disease), followed by maintenance therapy with adebrelimab in patients without progressive disease (non-PD)	Drug: Nodal residual-field radiotherapy group; Carboplatin/etoposide + thoracic residual-field RT, followed by maintenance adebrelimab in non-PD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival: Time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective tumor progression after starting maintenance therapy or all-cause death, whichever comes first.	From date of the first treatment to the first documented disease progression, assessed up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
L-PFS	local progression-free survival: Time from start of concurrent CCRT to first local progression post-maintenance or all-cause death, whichever occurs first	From date of the first treatment to the first documented disease progression, assessed up to 18 months
M-PFS	Metastasis-Progression Free Survival (M-PFS): Defined as the time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective distant tumor progression after starting maintenance therapy or all-cause death, whichever comes first.	From date of the first treatment to the first documented disease progression, assessed up to 18 months
OS	Overall Survival (OS): The time from the date of initiating study treatment at enrollment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last known alive.	From date of the first treatment to death due to any cause, assessed up to 18 months
DCR	Disease Control Rate (DCR): The proportion of patients with tumor shrinkage or stabilization maintained for a specified duration, including subjects with Complete Response (CR), Partial Response (PR), and Stable Disease (SD).	From date of the first treatment to18 months
DoR	Duration of Response (DoR): The time from the date of confirmed CR or PR by imaging to the occurrence of disease progression or death without progression	from the date of first documented CR or PR to disease progression or death, censored at last evaluable assessment; maximum follow-up of 18 months
ORR	Objective Response Rate (ORR): The proportion of subjects with tumor reduction achieving a predefined magnitude and maintained for a specified duration, including those with Complete Response (CR) and Partial Response (PR). Tumor objective response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).	Confirmed objective response observed within 18 months from start of treatment
AE	Incidence of adverse events assessed by CTCAE v5.0	From signing of informed consent through 30 days after last dose (or 90 days for serious AEs), assessed at the end of every cycle (each cycle = 21 days)

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: ARL-LS-SCLC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No