NCT06448312

A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Detailed description

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus pembrolizumab as firstline treatment for PD-L1 positive patients with locally advanced or metastatic non-small cell lung cancer.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SKB264	IV Infusion
DRUG	Pembrolizumab	IV Infusion

Timeline

• Start date: 2024-06-07
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-06-07
• Last updated: 2026-03-13

Locations

64 sites across 1 country: China