At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 55 target
Drug / intervention
HLX10 +2 moredrug
Likely dose
HLX10 300mgfrom record
Key inclusion· 8
- ✓Age 18-75 years
- ✓ECOG score 0-1
- ✓Histologically or cytologically confirmed small cell lung cancer
- ✓Limited stage disease confined to one side of thoracic cavity with ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicular lymph nodes
Key exclusion· 6
- ✕Histologically or cytologically confirmed mixed SCLC
- ✕Subjects suitable for surgery (unless refusing surgical treatment)
- ✕Previous systematic anti-tumor treatment for small cell lung cancer including radiotherapy, chemotherapy, and immunotherapy
- ✕Other active malignancies within 5 years or concurrently
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05443646Phase 2RecruitingUpdate OverdueUpdated 25mo ago · Completion was 24mo agoEnrollment Stalled
Long Recruiting
Update Overdue
A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences·interventional·Posted Jul 5, 2022·Updated May 7, 2024
In Brief
A Phase 2 clinical trial evaluating HLX10, hypofractionated radiotherapy, and 1 other intervention for Limited Stage Small Cell Lung Cancer. Currently recruiting, targeting 55 participants across 2 sites.
Signals
Enrollment appears stalled
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLimited Stage Small Cell Lung Cancer
CountriesChina
Collaborators--
Timeline
Phase 2RecruitingOverdue
2023202420252026
First PostedJul 2022
Enrollment StartSep 2022
Primary CompletionJun 2024
Study CompletionJun 2025
TodayJul 2026
First PostedJul 5, 2022
Enrollment StartSep 23, 2022
Primary CompletionJun 30, 2024
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.0 years ago
Interventions
HLX10drug
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
hypofractionated radiotherapyradiation
45Gy/3Gy/3week
Prophylactic Cranial Irradiation (PCI)radiation
25Gy/2.5Gy/2week