Clinical Trial

Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis

Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is to learn if the combination therapy with SKB264 and anlotinib works to treat EGFR-TKI-resistant, liver-metastatic non-squamous non-small cell lung cancer (NSCLC). It will also learn about the safety of the combination therapy with SKB264 and anlotinib. The main questions it aims to answer are: Does combination therapy with SKB264 and anlotinib increase response rate and disease control rate, prolong duation of response and progressioin-free survival. What medical problems do participants have when taking combination therapy with SKB264 and anlotinib? Researchers will compare combination therapy with SKB264 and anlotinib to a historical data (the response rate of other drugs reported in literature) to see if combination therapy with SKB264 and anlotinib works better to treat EGFR-TKI-resistant, liver-metastatic non-squamous non-small cell lung cancer (NSCLC). Participants will: 1. receive SKB264 4 mg/kg intravenously on a 14-day cycle, and take anti-H1/H2 antihistamines, acetaminophen, and dexamethasone is recommended before infusion for the first 4 infusions to prevent side effects; the regimen may be simplified starting from the 5th infusion. 2. take anlotinib 10 mg orally once daily for 14 consecutive days, followed by a 7-day rest period. 3. Visit the clinic once every week for checkups and tests
Trial Details
NCT Number NCT07545213
Lead Sponsor The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Non-small Cell Lung Cancer, EGFR Mutant Advanced Non-small Cell Lung Cancer
Enrollment 27 participants
Start Date 2026-04-20
Primary Completion 2028-02-15 (estimated)
Study Completion 2028-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-22