Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Meta… (NCT07545213) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis
China27 participantsStarted 2026-04-20
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
. Has previously received EGFR-TKI therapy for locally advanced or metastatic NSCLC with treatment failure (radiographic disease progression)；
. Life expectancy ≥12 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From first dose of study treatment until disease progression or last evaluable assessment, assessed every 6-12 weeks depending on treatment phase, up to approximately 24 months.
Trial details
NCT IDNCT07545213
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
. Adequate organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows:
. 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)；
. Known history of allergy to the study drugs or their components, history of immunodeficiency, or history of organ transplantation;
. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening; clinically severe pulmonary impairment due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy;
. Active infection requiring systemic therapy within 2 weeks prior to the first dose;
. According to the investigator's judgment, presence of concomitant diseases that seriously jeopardize patient safety or affect the patient's ability to complete the study, including but not limited to hypertension uncontrolled by medication, severe diabetes, active infection, etc;