NCT06853678

Second-line Immunotherapy for ES-SCLC

Selinexor Combined With Nab-paclitaxel and Adebrelimab as Second-line Treatment for ES-SCLC：A Prospective, Single-center, Single-arm Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

At present, the first-line standard treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) is immunotherapy combined with chemotherapy. For patients who relapse within 6 months after first-line chemotherapy, conventionally recommended chemotherapy drugs include topotecan, irinotecan, gemcitabine, paclitaxel or vinorelbine, etc., but due to limited benefits to patients, patients are also recommended to participate in relevant clinical studies. New treatment methods are constantly being explored in second-line treatment, including fluzoparib combined with adebelimumab. The current status of second-line treatment is still worrying. Selinexor is a class of nuclear export selective inhibitors (SINEs) for the export protein receptor XPO1. PO1 promotes the transport of mRNA and cargo proteins, including tumor suppressor proteins (TSPs), hormone receptors (GRs), and immune response regulators. Selinexor covalently binds to the XPO1 protein, blocking the export of TSPs and GRs and accumulating them in the nucleus, preventing the translation of oncoprotein mRNA, stopping the cell cycle process, and initiating apoptosis. Multiple in vitro and in vivo studies have verified that selinexor combined with chemotherapy/radiotherapy/targeted therapy exhibits significant anti-tumor activity. This study plans to use selinexor combined with adebrelimab and albumin-paclitaxel as a second-line treatment for ES-SCLC to explore the efficacy and safety of this regimen.

Conditions

• Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Interventions

Type	Name	Description
DRUG	Adebrelimab	1200mg,d1,iv,q3w
DRUG	Selinexor	40mg,twice weekly,d1, d3,oral,q3w
DRUG	Nab-paclitaxel	100mg/m2,d1,d8,d15,iv,q3w

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-07-01
• Completion: 2027-03-01
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: China