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A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients
Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
376
Start Date
2023-06-26
Completion Date
2026-09-30
Last Updated
2025-12-05
Healthy Volunteers
No
Conditions
Interventions
SKB264
intravenous (IV) infusion (Q2W)
Pemetrexed
500 mg/m2 intravenous (IV) infusion (Q3W)
Carboplatin
AUC 5 intravenous (IV) infusion (Q3W) 4cycles
Cisplatin
75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China