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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
Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
432
Start Date
2024-10-30
Completion Date
2028-12
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
SKB264
IV Infusion
Pembrolizumab
IV Infusion
pemetrexed
IV Infusion
carboplatin or cisplatin
IV Infusion
Locations (1)
Shanghai Oriental Hospital
Shanghai, China