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Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

NCT05443646 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-05-07

No results posted yet for this study

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

Conditions

  • Limited Stage Small Cell Lung Cancer

Interventions

DRUG

HLX10

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

RADIATION

hypofractionated radiotherapy

45Gy/3Gy/3week

RADIATION

Prophylactic Cranial Irradiation (PCI)

25Gy/2.5Gy/2week

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Nan Bi, Doctor · Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05443646 on ClinicalTrials.gov