NCT05870319

A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

A Randomized, Open-Label, Multicenter Phase 3 Study to Evaluate SKB264 Monotherapy Versus Pemetrexed in Combination With Platinum in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Detailed description

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy. The primary objective is to compare the efficacy and safety of SKB264 monotherapy versus pemetrexed in combination with platinum in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SKB264	intravenous (IV) infusion (Q2W)
DRUG	Pemetrexed	500 mg/m2 intravenous (IV) infusion (Q3W)
DRUG	Carboplatin	AUC 5 intravenous (IV) infusion (Q3W) 4cycles
DRUG	Cisplatin	75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles

Timeline

• Start date: 2023-06-26
• Primary completion: 2024-07-11
• Completion: 2026-09-30
• First posted: 2023-05-23
• Last updated: 2025-12-05

Locations

1 site across 1 country: China