A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC

StatusActive, Not Recruiting
PhasePhase 2
Started

Record status This record was last updated May 20, 2026 (before its estimated October 22, 2026 completion). Its status may not reflect the trial's current state.

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Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 31, 2026 to Oct 22, 2026
    • Study completion date: Aug 31, 2027 to Oct 31, 2027
    • Site details revised
    v4
  2. Primary completion date: Aug 31, 2025 to Aug 31, 2026v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Aug 31, 2026 to Aug 31, 2025
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 31, 2025 to Jun 24, 2025
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Trial Details
NCT Number NCT06812260
Lead Sponsor Shanghai Henlius Biotech
Conditions
(from sponsor)		 SCLC, Extensive Stage
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov