NCT06711900

A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.

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 chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SKB264	IV Infusion
DRUG	Pembrolizumab	IV Infusion
DRUG	pemetrexed	IV Infusion
DRUG	carboplatin or cisplatin	IV Infusion

Timeline

• Start date: 2024-10-30
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2024-12-02
• Last updated: 2026-02-05

Locations

1 site across 1 country: China