Second-line Immunotherapy for ES-SCLC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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 criteria
Qualifiers
Age ≥ 18 years old, male or female;
ECOG PS score 0-1 points;
Expected survival period is not less than 12 weeks;
Patients with pathologically (histologically or cytologically) confirmed small cell lung cancer (according to the 2015 classification of the World Health Organization);
Disqualifiers
Any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who can be controlled only by hormone replacement therapy can be included]; subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, alopecia, type I diabetes or asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included; asthma patients who require bronchodilators for medical intervention are not included);
Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, untreated active hepatitis B (HBsAg positive or HBV DNA ≥ 500 IU/ml and abnormal liver function), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method and liver function is abnormal) or co-infection with hepatitis B and hepatitis C;
Subjects who need systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent dose of similar hormones) or other immunosuppressants within 14 days before the first use of the trial drug;
Subjects who received live attenuated vaccines within 4 weeks before the first dose or planned to receive them during the study;
Trial design
Treatments tested in this trial
- Adebrelimab
- Selinexor
- Nab-paclitaxel
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov