Clinical Trial: NCT06448312
A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-05-08 |
Study Overview
Brief Summary
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Official Title
A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: SKB264
- Drug: Pembrolizumab
Other Study ID Numbers
- SKB264-Ⅲ-12
Start Date (Actual)
2024-06-07
Primary Completion Date (Estimated)
2026-11
Study Completion Date (Estimated)
2026-11
Enrollment (Estimated)
406
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-05-08 |
Study Overview
Brief Summary
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Official Title
A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: SKB264
- Drug: Pembrolizumab
Other Study ID Numbers
- SKB264-Ⅲ-12
Start Date (Actual)
2024-06-07
Primary Completion Date (Estimated)
2026-11
Study Completion Date (Estimated)
2026-11
Enrollment (Estimated)
406
Study Type
Interventional
Phase
Phase 3