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OncoMatch/Clinical Trials/NCT06485544

Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial

Is NCT06485544 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Adebrelimab + Etoposide + Platinum-based Therapy and Etoposide + Platinum-based Therapy for small cell lung cancer (sclc).

Phase 2RecruitingTang-Du HospitalNCT06485544Data as of May 2026

Treatment: Adebrelimab + Etoposide + Platinum-based Therapy · Etoposide + Platinum-based TherapyThis study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer (SCLC). The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University. A total of 104 patients with stage IA-IIIB SCLC (stage IIIB limited to T1-4N1-2M0) will be enrolled and randomized 1:1 to receive either Adebrelimab plus chemotherapy or chemotherapy alone. Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery. Treatment will be discontinued if patients experience disease progression, intolerable drug-related adverse events, withdrawal of informed consent, or other specified conditions during the study. Effectiveness and safety outcomes will be monitored throughout the trial. The primary objective is to evaluate pathological complete response (pCR) with Adebrelimab combination therapy. Secondary objectives include assessing event-free survival (EFS), major pathological response (mPR), objective response rate (ORR), disease-free survival (DFS), and safety.

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Disease stage

Required: Stage I, II, IIIA, IIIB

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiation therapy

without prior treatment with radiation

Cannot have received: chemotherapy

without prior treatment with chemotherapy

Cannot have received: targeted therapy

without prior treatment with targeted therapy

Cannot have received: surgery

without prior treatment with surgery

Cannot have received: traditional Chinese medicine

without prior treatment with traditional Chinese medicine

Lab requirements

Blood counts

ANC ≥ 1.5 × 10^9/L; PLT ≥ 100 × 10^9/L; Hb ≥ 90 g/L

Kidney function

Serum creatinine (sCr) ≤ 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (Cockcroft-Gault formula)

Liver function

TBIL ≤ 1.5 × ULN; ALT, AST ≤ 2.5 × ULN (if abnormal liver function due to liver metastasis, ≤ 5 × ULN)

Cardiac function

sufficient cardiopulmonary function to tolerate planned lung resection surgery; INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN; LVEF ≥ 50% by cardiac ultrasound

Normal organ function, as defined by the following criteria: (1) Hematological criteria ... (2) Biochemical criteria ... (3) Coagulation function ... sufficient cardiopulmonary function to tolerate planned lung resection surgery.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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