Overview

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 Ca

Status:
NOT_YET_RECRUITING

Trial end date:
2031-01-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE2

Details

Lead Sponsor:

Shanghai Henlius Biotech

Treatments:

130-nm albumin-bound paclitaxel
Carboplatin
HLX07
pembrolizumab