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Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer

NCT07583550

Not Yet RecruitingPhase 2

Sponsor: Jiangmen Central Hospital

Conditions: Lung, Radiotherapy

Interventions: Etoposide, Cisplatin, Carboplatin, Adebrelimab, Thoracic Radiotherapy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years and ≤75 years;
2. Histologically or cytologically confirmed SCLC;
3. No malignant pleural effusion or pericardial effusion;
4. No prior history of thoracic radiotherapy or thoracic surgery;
5. No prior systemic anti-tumor therapy;
6. ECOG performance status 0-2, with a life expectancy of ≥12 weeks;
7. At least one measurable lesion per RECIST 1.1 criteria;
8. No history of interstitial pneumonia;
9. No history of immune-related pneumonitis;
10. No history of autoimmune diseases;
11. No history of significant active pulmonary infection;
12. No use of corticosteroid therapy within 14 days prior to enrollment;
13. No Grade ≥3 hematologic toxicity or hepatic/renal impairment;
14. No brainstem metastases and no significant neurological symptoms;
15. For subjects with coexisting HBV/HCV infection, hepatic impairment ≤ Grade 1 after prior active antiviral therapy;
16. All subjects have provided written informed consent;

Exclusion Criteria:

1. Presence of interstitial pneumonia or infectious fever prior to treatment;
2. Comorbid autoimmune diseases or long-term oral corticosteroid use (including those who received oral corticosteroids within 14 days prior to treatment);
3. Prior history of thoracic radiotherapy or thoracic surgery;
4. Presence of Grade ≥3 hematologic toxicity or hepatic/renal impairment;
5. Hypersensitivity to adebrelimab;
6. Significant respiratory symptoms that preclude tolerance to radiotherapy;
7. Active hepatitis B or C infection, currently on antiviral therapy, and with liver function impairment of Grade 2 or above;
8. Presence of pleural effusion or pericardial effusion;