At a glance
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A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating HLX10, carboplatin/cisplatin-etoposide, and 3 other interventions for Limited-Stage Small Cell Lung Cancer. Active but no longer recruiting, targeting 511 participants across 129 sites in 11 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice. Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.
Standard Thoracic Radiotherapy
Placebo Q3W
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.