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
Aged ≥ 18 years, both male and female;
ECOG performance status score of 0-1;
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) and not amenable to curative surgery and/or curative radiotherapy (with or without concurrent chemotherapy), according to the IASLC 9th edition lung cancer TNM staging system.
At least one measurable target lesion in the liver (according to RECIST version 1.1);
Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
Previous treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors;
Has had other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
Known or screening-detected symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis (Note: ① Patients who have been treated and have stable disease for ≥4 weeks and have discontinued systemic corticosteroids (at any dose) for >3 days may be enrolled. ② Patients with asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, and no lesion >1.5 cm) are eligible but require regular brain imaging as part of disease site evaluation)；
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator