Actively Recruiting
Second-line Immunotherapy for ES-SCLC
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-03-03
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Second-line Immunotherapy for ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- ECOG performance status score of 0-1
- Expected survival of at least 12 weeks
- Pathologically confirmed small cell lung cancer
- Extensive-stage small cell lung cancer confirmed by imaging
- Measurable tumor lesions with a long diameter of at least 10 mm on CT scan
- Failed standard first-line treatment prior to enrollment
- Agree to provide tumor tissue samples for research
- Normal main organ function without severe abnormalities or immunodeficiency
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment and agree to use effective contraception during the study and for 90 days after the last treatment
- Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for 90 days after the last treatment
- Voluntarily agree to participate and sign informed consent with good compliance
You will not qualify if you...
- Active autoimmune disease or history of autoimmune disease with expected recurrence, except controlled hypothyroidism or certain skin diseases
- Congenital or acquired immune deficiency such as HIV infection or active hepatitis B or C
- Need for systemic corticosteroids greater than 10 mg/day prednisone equivalent or other immunosuppressants within 14 days before first treatment
- Receipt of live attenuated vaccines within 4 weeks before first dose or planned during study
- Prior or current use of other anti-tumor treatments for small cell lung cancer
- History of other malignant tumors within 5 years, except certain treated cancers
- Evidence of lung diseases such as pulmonary fibrosis, interstitial pneumonia, or severe lung impairment
- Grade II or higher myocardial ischemia or infarction, poorly controlled arrhythmias, or certain heart failure conditions
- Proteinuria detected by urine tests or 24-hour urine protein over 1.0 g
- Thrombotic diseases requiring long-term anticoagulation or high-dose antiplatelet therapy
- Use of systemic antibiotics for 7 or more days within 4 weeks before first dose or unexplained fever over 38.5°C during screening
- History of allogeneic organ or stem cell transplantation
- Pregnant or lactating women or those unwilling or unable to use effective contraception
- Known allergies or intolerances to study drugs or excipients
- Any condition deemed by investigators to pose harm or prevent study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
Y
Yanwei Li, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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