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)；
Single group
SKB264
DrugSKB264 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. anlotinib 10 mg orally once daily for 14 consecutive days, followed by a 7-day rest period.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of subjects who achieve a best overall response of complete response (CR) or partial response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of subjects who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to RECIST version 1.1.
Duration of Response (DOR)
Duration of response is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression per RECIST version 1.1 or death due to any cause, whichever occurs first.
Time to Response (TTR)
Time to response is defined as the time from the first dose of study treatment to the first documented objective response (CR or PR) as assessed by the investigator according to RECIST version 1.1.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST version 1.1 as assessed by the investigator, or death due to any cause, whichever occurs first.
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
