RecruitingPhase 2NCT05443646

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

55 participants

Start Date

Sep 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multi-center, Single-arm Phase II study to evaluate the clinical efficacy and safety of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing serplulimab, an immunotherapy drug, given after standard chemoradiation therapy in patients with limited-stage small cell lung cancer (SCLC) — a type of lung cancer that is confined to one side of the chest — to see if it can prevent the cancer from coming back. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with limited-stage small cell lung cancer (confirmed by biopsy or cell sample) - You are in good overall health (ECOG performance status 0-1) - You have not had any prior treatment for this cancer - Your organ function is adequate **You may NOT be eligible if...** - Your cancer has spread to both sides of the chest or beyond - You have had prior lung cancer treatment - You have significant autoimmune disease or major organ problems - 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

DRUGHLX10

HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. 300mg Q3W

RADIATIONhypofractionated radiotherapy

45Gy/3Gy/3week

RADIATIONProphylactic Cranial Irradiation (PCI)

25Gy/2.5Gy/2week


Locations(2)

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, China

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

View Full Details on ClinicalTrials.gov

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NCT05443646


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