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
NCT06711900 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432
Last updated 2026-02-05
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.
Conditions
Interventions
- DRUG
-
SKB264
IV Infusion
- DRUG
-
IV Infusion
- DRUG
-
pemetrexed
IV Infusion
- DRUG
-
carboplatin or cisplatin
IV Infusion
Sponsors & Collaborators
-
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-30
- Primary Completion
- 2026-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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