RecruitingNot ApplicableNCT06853678

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

30 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an immunotherapy treatment combination for people with extensive-stage small cell lung cancer (a fast-growing type of lung cancer) whose cancer has come back or stopped responding after first-line treatment. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with extensive-stage small cell lung cancer confirmed by biopsy - Your cancer has measurable tumors on imaging - Your cancer has progressed after first-line treatment - You are in good enough health to carry out daily activities - You have adequate blood counts and heart, lung, liver, and kidney function **You may NOT be eligible if:** - You have an active autoimmune disease - You have HIV, active hepatitis B or C, or an immune deficiency - You need to take steroids or immunosuppressive drugs regularly - You have significant heart disease (e.g., heart failure, recent heart attack, or irregular heartbeat) - You have active lung fibrosis or interstitial lung disease - You have had a prior organ or bone marrow transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab

1200mg,d1,iv,q3w

DRUGSelinexor

40mg,twice weekly,d1, d3,oral,q3w

DRUGNab-paclitaxel

100mg/m2,d1,d8,d15,iv,q3w


Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

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NCT06853678


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