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A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer

StatusNot Yet Recruiting
PhasePhase 2/3
Started2026-03
View on ClinicalTrials.gov ↗
The study consists of two parts: Part I is a randomized, double-blind, multicenter, parallel-controlled phase II clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab and chemotherapy as first-line treatment in patients with sqNSCLC. Part II is a randomized, double-blind, multicenter, parallel-controlled phase III clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy as first-line treatment in patients with sqNSCLC.
Trial Details
NCT Number NCT07318883
Lead Sponsor Shanghai Henlius Biotech
Conditions Squamous NSCLC
Enrollment 720 participants
Start Date 2026-03
Primary Completion 2031-01 (estimated)
Study Completion 2031-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-06