NCT07318883

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

A Randomized, Double-Blind, Multicenter, Phase II/III Clinical Study to Evaluate HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Patients With Advanced Squamous Non-Small Cell Lung Cancer (sqNSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Squamous NSCLC

Interventions

Type	Name	Description
DRUG	HLX07	Intravenous infusion (IV), once every 3 weeks (Day 1 of each cycle \[D1\]).
DRUG	HLX07 placebo	Intravenous infusion (IV), once every 3 weeks (Day 1 of each cycle \[D1\]).
DRUG	Serplulimab	IV, once every 3 weeks (D1).
DRUG	Pembrolizumab	IV, once every 3 weeks (D1).
DRUG	Carboplatin	IV, once every 3 weeks (D1).
DRUG	Paclitaxel or Nab-Paclitaxel	Paclitaxel: IV, once every 3 weeks (D1). Nab-paclitaxel: IV, once every 3 weeks (D1, 8, 15).

Timeline

• Start date: 2026-03-01
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study