RecruitingPhase 2NCT06295926

Serplulimab Combined With CCRT for LS-SCLC.

A Single-arm Phase II Clinical Trial of Serplulimab Combined With Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer(LS-SCLC).


Sponsor

Peking Union Medical College Hospital

Enrollment

96 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding serplulimab (an immunotherapy drug) to standard combined chemotherapy and radiation treatment improves outcomes for people with limited-stage small cell lung cancer — meaning the cancer is confined to one area of the chest. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of limited-stage small cell lung cancer (Stage II or III) - You have not had any prior chemotherapy, radiation, immunotherapy, or targeted therapy for this cancer - You are generally healthy and active (good performance status) - You have measurable cancer on scans - You are not pregnant or breastfeeding and are willing to use contraception during and for 6 months after treatment **You may NOT be eligible if...** - Your small cell lung cancer is extensive (spread widely beyond the chest) - You have had previous cancer treatment for small cell lung cancer - You have an active autoimmune disease requiring ongoing treatment - You have HIV, active hepatitis B or C, or active tuberculosis - You have received a live vaccine within 30 days before starting - You have a history of serious lung inflammation or pneumonia requiring steroids 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

DRUGSerplulimab

Undergo 4 cycles of synchronous radiotherapy and chemotherapy combined with Sintilimab immunotherapy, followed by Sintilimab monotherapy for maintenance treatment until disease progression or up to 1 year.


Locations(1)

Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06295926


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