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New treatment option for Leptomeningeal Metastasis
Official title Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study
ClinicalTrials.gov ID: NCT07398599
What this study is testing
What is a combined regimen consisting of double-dose third-generation EGFR-TKI, bevacizumab, and intrathecal chemotherapy in patients?
a combined regimen consisting of double-dose third-generation EGFR-TKI, bevacizumab, and intrathecal chemotherapy in patients is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for leptomeningeal metastasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to explore the efficacy and safety of double-dose third-generation EGFR-TKI combined with bevacizumab and intrathecal chemotherapy in treating advanced non-small cell lung cancer (NSCLC) patients with leptomeningeal metastasis that progressed after prior standard-dose third-generation EGFR-TKI treatment. It also aims to investigate the correlation between cerebrospinal fluid genetic characteristics and prognosis as well as subsequent efficacy prediction in patients with leptomeningeal metastasis after resistance to standard-dose third-generation EGFR-TKI.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Aged ≥ 18 years at the time of signing the informed consent form, regardless of gender.
- Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC), staged as IV according to the 8th edition of the...
- Presence of EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation).
- Leptomeningeal metastasis (LM) progression after standard-dose first-, second-, or third-generation EGFR-TKI treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
You likely can't join if
- Major surgery within 4 weeks prior to the start of study treatment, or need for major surgery during the study.
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Active bacterial/fungal/viral infections requiring intravenous antibiotic therapy.
- Drug-induced pneumonitis or interstitial lung disease, or evidence of clinically significant active pulmonary disease.
- Severe cardiovascular events within 6 months prior to enrollment, including cerebrovascular accident, deep vein thrombosis, or pulmonary embolism.
- Significant cardiovascular disease, such as New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina...
See the full eligibility criteria
- Aged ≥ 18 years at the time of signing the informed consent form, regardless of gender.
- Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC), staged as IV according to the 8th edition of the IASLC TNM classification (2015).
- Presence of EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation).
- Leptomeningeal metastasis (LM) progression after standard-dose first-, second-, or third-generation EGFR-TKI treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate major organ function, defined as: hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count (PLT) ≥ 100 × 10\^9/L, white blood cell count (WBC) ≥ 3.0 × 10\^9/L and ≤ 10.0 ×...
- At least 21 days since the last radiotherapy (including whole-brain radiotherapy or local radiotherapy for brain metastases).
- Expected survival ≥ 3 months.
- Ability to swallow oral medications (or receive crushed medications via gastrostomy tube if unable to swallow).
- For women: Agreement to use effective contraception (e.g., surgical sterilization or protocol contraception) within 14 days prior to enrollment, during the study, and for 3 months after the last study drug...
- For men: Agreement to use effective contraception (e.g., surgical sterilization or protocol contraception) during the study and for 3 months after the last study drug administration.
- Voluntary participation, signed informed consent, and willingness to comply with study procedures and protocols.
- Major surgery within 4 weeks prior to the start of study treatment, or need for major surgery during the study.
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Active bacterial/fungal/viral infections requiring intravenous antibiotic therapy.
- Drug-induced pneumonitis or interstitial lung disease, or evidence of clinically significant active pulmonary disease.
- Severe cardiovascular events within 6 months prior to enrollment, including cerebrovascular accident, deep vein thrombosis, or pulmonary embolism.
- Significant cardiovascular disease, such as New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, symptomatic arrhythmias requiring treatment, or corrected QT interval (QTcF) \>...
- History of other systemic malignant tumors within the past 5 years (except for cured basal cell carcinoma, carcinoma in situ of the cervix, and ovarian cancer).
- Use of drugs or supplements known to be strong inducers of CYP3A4.
- Known severe allergy to any study drug or its excipients.
- Pregnancy, lactation, or refusal of effective contraception by patients of childbearing potential.
- History of definite neurological or psychiatric disorders (including epilepsy and dementia).
- Other conditions deemed unsuitable for enrollment by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.