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To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

StatusActive, Not Recruiting
PhasePhase 3
Started2022-11-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 21, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-10-20
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v25
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-09-30→2026-02-28
Completion date2025-12-31→2027-12-31
Study sites99→67
2025-05-22
Study Status, Contacts/Locations v24
Study sitesdetails revised at 6 of 99 sites
2025-01-22
Study Status, Contacts/Locations v23
Primary completion date2025-04-30→2025-09-30
Study sites99 entries, revised
AscensionHenry Ford Health Providence Southfield Hospital CK Potluri Cancer Center
2024-11-18
Study Status, Contacts/Locations v22
Primary completion date2024-10-31→2025-04-30
Study sitesdetails revised at 5 of 99 sites
2024-10-17
Study Status, Contacts/Locations v21
Study sites87→99
Show 20 earlier versions
2024-08-27
Study Status, Contacts/Locations v20
Study sites87 entries, revised
LutheranEastern MedicalConnecticut Hematology and Oncology Associates Clermont Oncology Center Northwest Cancer CenterCenters UnitedSaint MedicalLuke's Group AmericanHospital OncologyCancer Partners of Maryland, PA The Toledo ClinicInstitute
2024-06-24
Study Status, Contacts/Locations v19
Study sites84→87
2024-06-20
Study Status, Study Design v18
PhasePhase 2→Phase 3
2024-06-13
Study Status, Study Design v17
PhasePhase 3→Phase 2
2024-05-30
Study Status v16
Primary completion date2024-06-01→2024-10-31
2024-05-07
Study Status, Contacts/Locations v15
Study sites83→84
2024-04-29
Study Status, Contacts/Locations v14
Study sites79→83
2024-02-29
Study Status, Contacts/Locations v13
Study sites69→79
2024-02-05
Study Status, Contacts/Locations v12
Study sites64→69
2024-01-10
Study Status, Contacts/Locations v11
Study sites57→64
2023-12-25
Study Status, Eligibility v10
Eligibility criteria+664 characters
Inclusion Criteria: Voluntary participation in clinical studies. Male or female aged ≥ 18 years at the time of signing the ICF. Histologically or cytologically diagnosed with ES-SCLC (acco [...] oup staging system). No prior systemic therapy for ES-SCLC. At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization. Major organs are functioning well. Every effort should be made to provide tumor tissues for the determination of PD-L1 expression. An ECOG PS score of 0 or 1. An expected survival ≥ 12 weeks. Subjects with prior denosumab use that can and agree t [...] [...]
2023-11-29
Study Identification, Study Status, Contacts/Locations v9
Study sites38→57
2023-08-29
Study Status, Contacts/Locations v8
Study sites15→38
2023-06-28
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures v7
InterventionsAtezolizumab + chemotherapy (carboplatin-etoposide) (Drug), HLX10 + chemotherapy (carboplatin-etoposide) (Drug)→Atezolizumab + chemotherapy (carboplatin-etoposide) (Drug), Serplulimab + chemotherapy (carboplatin-etoposide) (Drug)
Secondary endpointsdetails revised at 3 of 6 entries
Study title+6 characters
To Evaluate Efficacy and Safety of HLX10Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
2023-05-31
Study Status, Contacts/Locations v6
Re-verified, no change to tracked fields
2023-03-22
Study Status, Contacts/Locations v5
Study sites11→15
2022-12-12
Study Status, Contacts/Locations v4
Start dateestimated 2022-10-12→confirmed 2022-11-18
Study sites5→11
2022-10-18
Study Status, Contacts/Locations v3
Study sites1→5
2022-10-12
Study Status v2
Start date2022-10-20→2022-10-12
2022-10-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2022-09-01→2022-10-20
Study sites0→1
2022-07-19
Original filing
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: * Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) * Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Trial Details
NCT Number NCT05468489
Lead Sponsor Shanghai Henlius Biotech
Conditions Extensive Stage Small Cell Lung Cancer
Enrollment 200 participants
Start Date 2022-11-18
Primary Completion 2026-02-28 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-21