Second-line Immunotherapy for ES-SCLC

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06853678
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
Jul 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Immunotherapy combined with chemotherapy

Primary Outcome Measure

Progression-free survival，PFS [ Time Frame: 24months ]

Central Contacts

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