RecruitingPhase 2NCT06350162

Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC

A Randomized Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Combination Therapy With Serplulimab and RT in Patients With ES-SCLC Who Have Not Progressed After Treat With Serplulimab Combined Chemotherapy


Sponsor

Zhejiang Cancer Hospital

Enrollment

100 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer .


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding targeted radiation therapy to an immunotherapy-based regimen improves long-term outcomes for people with extensive-stage small cell lung cancer (ES-SCLC) — the more advanced form of this aggressive type of lung cancer — after initial chemotherapy with serplulimab achieves disease control. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with extensive-stage small cell lung cancer - You have already completed combination chemotherapy with serplulimab and your cancer responded (complete response, partial response, or stable disease) - You have not received prior systemic therapy for ES-SCLC - You have at least one measurable lesion and are in good general health (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer progressed during initial chemotherapy - You have uncontrolled brain metastases - You have serious heart, lung, or kidney problems - You have active autoimmune disease - 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

DRUGSerplulimab

4.5mg/kg,IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days.

RADIATIONChest Radiation

30Gy-45Gy/QD/3Gy


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, China

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NCT06350162


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