NCT06764368

Phase II Study of Adebrelimab, Chemotherapy, and Apatinib for Advanced Pulmonary Neuroendocrine Tumors

A Phase II, Single-arm, Multicenter Clinical Study of Adebrelimab Combined With Chemotherapy and Apatinib as First-line Treatment for Unresectable Locally Advanced or Metastatic Pulmonary Neuroendocrine Tumors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated research project aimed at exploring the efficacy and safety of Adebrelimab combined with chemotherapy and Apatinib as first-line treatment for unresectable locally advanced or metastatic pulmonary neuroendocrine tumors. This is an experimental study that has been reviewed and approved by the Ethics Committee of Beijing Chest Hospital. The study plans to enroll 39 treatment-naïve patients with unresectable locally advanced or metastatic pulmonary neuroendocrine carcinoma, who will receive first-line treatment with Adebrelimab combined with chemotherapy and Apatinib to evaluate its efficacy and safety.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Adebrelimab + Apatinib	Induction Phase: Subjects will receive Adebrelimab (1200 mg, Day 1) + Etoposide (100 mg/m2, Days 1-3) + Carboplatin (AUC = 4-5, Day 1) / Cisplatin (75 mg/m2, Day 1) (as determined by the investigator) + Apatinib (250 mg, orally, once daily) in 3-week cycles (Q3W) for 4 to 6 cycles. Maintenance Phase: Adebrelimab (1200 mg, Day 1) + Apatinib (250 mg, orally, once daily) will be administered for 1 year or until one of the following occurs: disease progression, intolerable toxicity, withdrawal of informed consent by the subject, voluntary withdrawal from the study, or other protocol-specified reasons.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-12-31
• Completion: 2028-06-01
• First posted: 2025-01-08
• Last updated: 2025-01-08