Low-dose chest radiotherapy with adebrelimab and chemotherapy for extensive-stage small cell lung cancer

Trial details

Who runs it

Jiangmen Central Hospital

Trial code

NCT07583550

Record updated

22 September 2026

Original description

This study is a multicenter, prospective investigation aiming to evaluate the efficacy and safety of low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions) combined with 4-6 cycles of systemic chemotherapy concurrently with Adebrelimab, followed by Adebrelimab maintenance therapy for up to two years, in subjects with extensive-stage small cell lung cancer (ES-SCLC). Additionally, immunohistochemical detection of the expression levels of four key transcriptional proteins-YAP1, NEUROD1, ASCL1, and POU2F3-will be performed to guide the molecular subtyping of SCLC. Based on these findings, we will explore the differential therapeutic outcomes of this regimen across distinct molecular subtypes (A/N/P/Y/I/AN/QN), with the goal of identifying the subject population most likely to benefit from this treatment modality, thereby optimizing clinical decision-making.Read full original descriptionShow less

Efficacy and Safety of Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy and Sequential Adebrelimab Maintenance Therapy for Extensive-stage Small Cell Lung Cancer: A Prospective, Multicenter Phase II Study

This study is a multicenter, prospective investigation aiming to evaluate the efficacy and safety of low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions) combined with 4-6 cycles of systemic chemotherapy concurrently with Adebrelimab, followed by Adebrelimab maintenance therapy for up to two years, in subjects with extensive-stage small cell lung cancer (ES-SCLC). Additionally, immunohistochemical detection of the expression levels of four key transcriptional proteins-YAP1, NEUROD1, ASCL1, and POU2F3-will be performed to guide the molecular subtyping of SCLC. Based on these findings, we will explore the differential therapeutic outcomes of this regimen across distinct molecular subtypes (A/N/P/Y/I/AN/QN), with the goal of identifying the subject population most likely to benefit from this treatment modality, thereby optimizing clinical decision-making.

Inclusion: Age ≥18 years and ≤75 years; Histologically or cytologically confirmed SCLC; No prior thoracic radiotherapy or thoracic surgery; No prior systemic anti-tumor therapy; ECOG performance status 0-2 and life expectancy ≥12 weeks; At least one measurable lesion per RECIST 1.1; Adequate bone marrow function to tolerate anti-tumor therapy: WBC ≥3×10⁹/L, Hb ≥80 g/L, PLT ≥75×10⁹/L, and absolute neutrophil count (NEUT) ≥1.5×10⁹/L; Essentially normal hepatic and renal function: 8.1. Serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min; 8.2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN is acceptable in patients with liver metastases); 8.3. Total bilirubin (TBIL) ≤1.5×ULN; 8.4. Albumin ≥30 g/L and prealbumin ≥150 g/L; Urine protein ≤1+ or <1000 mg/24h; All patients have provided full informed consent.

Exclusion: Pre-existing interstitial lung disease (with or without clinical symptoms) or uncontrolled infectious pneumonia (e.g., accompanied by cough, fever >38°C, dyspnea, tachypnea, etc.) prior to treatment; Concomitant autoimmune disease, or long-term oral corticosteroid use (including oral corticosteroids within 14 days before treatment); Severe cardiac or cerebrovascular disease, including: New York Heart Association (NYHA) class ≥2 heart failure; acute coronary syndrome (e.g., myocardial infarction, unstable angina) within 6 months before enrollment; frequent and uncontrolled arrhythmias (excluding transient atrial fibrillation/flutter) despite antiarrhythmic therapy for ≥2 weeks; acute cerebrovascular events (e.g., transient ischemic attack, cerebral infarction, cerebral hemorrhage); Allergy to adebrelimab; Positive HIV antibody, active hepatitis B (HBV-DNA >10³ IU/mL), active hepatitis C (HCV-RNA above the lower limit of detection of the study site), active pulmonary tuberculosis (defined as: fever, night sweats, chest pain, etc.; or acid-fast bacilli found in sputum or bronchoalveolar lavage fluid; or chest CT showing active signs such as patchy infiltrates or cavities), or positive syphilis antibody; MRI evidence of leptomeningeal, brainstem, or spinal cord metastases, or symptomatic brain metastases (e.g., headache, nausea, vomiting, visual impairment, or visual field defects); Hypertension poorly controlled despite two antihypertensive agents (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg); Any deep vein thrombosis (allowed if stable on low-molecular-weight heparin or similar therapy for >2 weeks), arterial thrombosis, or pulmonary embolism; Poorly controlled blood glucose (defined as: 1. two consecutive fasting blood glucose values >10 mmol/L; or 2. HbA1c ≥8%), or diabetic gangrene; Moderate or large pleural effusion (maximum depth >3 cm on chest ultrasound or CT, estimated volume >500 mL) or moderate or large pericardial effusion (maximum diastolic width >1 cm on echocardiography, estimated volume >100 mL), or poorly controlled pleural/pericardial effusion (defined as requiring ≥2 drainage procedures within 1 month). Patients may be enrolled if effusion becomes minimal or undetectable after drainage; Pregnant or lactating women, or women of childbearing potential who are unwilling to use effective contraception during the study and for at least 6 months after the last dose.

ClinicalTrials.gov NCT07583550