Clinical Trial: NCT05870319
A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients
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
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
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: SKB264
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Cisplatin
Other Study ID Numbers
- SKB264-Ⅲ-09
Start Date (Actual)
2023-06-26
Primary Completion Date (Actual)
2024-07-11
Study Completion Date (Estimated)
2026-09-30
Enrollment (Actual)
376
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
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
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: SKB264
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Cisplatin
Other Study ID Numbers
- SKB264-Ⅲ-09
Start Date (Actual)
2023-06-26
Primary Completion Date (Actual)
2024-07-11
Study Completion Date (Estimated)
2026-09-30
Enrollment (Actual)
376
Study Type
Interventional
Phase
Phase 3