NCT06350162

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

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 . Immunotherapy with monoclonal antibodies, such as Serplulimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to Serplulimab may extend the time without extensive small cell lung cancer growing or spreading compared to Serplulimab alone.

Conditions

• Extensive Stage Lung Small Cell Cancer

Interventions

Type	Name	Description
DRUG	Serplulimab	4.5mg/kg,IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days.
RADIATION	Chest Radiation	30Gy-45Gy/QD/3Gy

Timeline

• Start date: 2023-10-18
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-04-05
• Last updated: 2024-04-05

Locations

1 site across 1 country: China