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RECRUITING
NCT06853678
NA

Second-line Immunotherapy for ES-SCLC

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-02-28

Completion Date

2027-03-01

Last Updated

2025-03-03

Healthy Volunteers

No

Interventions

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

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China