Clinical Trial

A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-05-11; most recent amendment 2026-05-05.
Status change: Recruiting → Active, Not Recruiting 2025-11-13
Status change: Not Yet Recruiting → Recruiting 2023-08-07
Trial Details
NCT Number NCT05870319
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 376 participants
Start Date 2023-06-26
Primary Completion 2024-07-11 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-08