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A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started2022-05-17
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 13, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-01-12
Study Status, Outcome Measures v16
Primary completion date2025-07-30→2026-06-30
Completion date2026-12-30→2028-05-30
Secondary endpoints1 to 3 entries
Objective response rate (ORR) Duration of remission (DOR)
Primary endpoints1 to 2 entries
Overall survival (OS) Progression-free survival (PFS)
2025-01-23
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 482→confirmed 511
Study sitesdetails revised at 129 of 129 sites
2024-08-28
Study Status, Contacts/Locations v14
Primary completion date2024-12-30→2025-07-30
Completion date2026-06-30→2026-12-30
Study sitescontacts updated at 1 of 129 sites
2024-02-29
Study Status, Contacts/Locations v13
Study sites128→129
2024-02-20
Study Status, Contacts/Locations v12
Study sites121→128
Show 11 earlier versions
2023-12-03
Study Status, Arms and Interventions v11
InterventionsPlacebo (Drug), Prophylactic Cranial Irradiation (PCI) (Radiation), Serplulimab (Drug), Thoracic radiotherapy (Radiation)…→HLX10 (Drug), Placebo (Drug), Prophylactic Cranial Irradiation (PCI) (Radiation), Thoracic radiotherapy (Radiation)…
2023-10-08
Study Status, Contacts/Locations v10
Re-verified, no change to tracked fields
2023-08-27
Study Status, Contacts/Locations v9
Study sites91→121
2023-08-07
Study Status, Contacts/Locations v8
Study sites79→91
2023-07-10
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions v7
InterventionsHLX10 (Drug), Placebo (Drug), Prophylactic Cranial Irradiation (PCI) (Radiation), Thoracic radiotherapy (Radiation)…→Placebo (Drug), Prophylactic Cranial Irradiation (PCI) (Radiation), Serplulimab (Drug), Thoracic radiotherapy (Radiation)…
Study description+12 characters
Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio. Arm A (HLX10Serplulimab arm): HLX10Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent [...]
Study title+6 characters
A Study to Evaluate the Efficacy and Safety of HLX10Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
2023-06-29
Study Status, Contacts/Locations v6
Study sites84→79
2023-01-12
Study Status, Contacts/Locations v5
Study sites3→84
2022-10-28
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 3 sites
2022-10-19
Study Status, Contacts/Locations v3
Study sites1→3
2022-08-17
Study Status, Arms and Interventions, Eligibility v2
Start date2022-05-05→2022-05-17
Eligibility criteria-17 characters
Inclusion Criteria: Male or female, aged ≥18 years when signing the ICF. Histologically or cytologically diagnosed with SCLC. Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of t [...]
2022-06-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2022-04-25
Original filing
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
Trial Details
NCT Number NCT05353257
Lead Sponsor Shanghai Henlius Biotech
Conditions Limited-Stage Small Cell Lung Cancer
Enrollment 511 participants
Start Date 2022-05-17
Primary Completion 2026-06-30 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-13