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Clinical Trial NCT07398599 for Leptomeningeal Metastasis, Lung Neoplasms, Non-Small Cell Lung Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study 30

Recruiting
Clinical Trial NCT07398599 is an interventional study for Leptomeningeal Metastasis, Lung Neoplasms, Non-Small Cell Lung Cancer that is recruiting. It started on 15 February 2026 with plans to enroll 30 participants. Led by Second Affiliated Hospital of Nanchang University, it is expected to complete by 30 December 2027. The latest data from ClinicalTrials.gov was last updated on 10 February 2026.
Brief Summary
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...Show More
Detailed Description
  1. Study Overview This is a prospective, single-arm Phase II interventional clinical trial initiated by the Second Affiliated Hospital of Nanchang University, with funding from the Wu Jieping Medical Foundation. The study will be conducted from December 2025 to December 2027 (Version V1.0, dated November 20, 2025) and led by Principal Investigator Cai Jing (contact number: 0791-86260752). The core objective is to eva...
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Official Title

To Explore the Efficacy and Safety of Double-dose Third-generation EGFR-TKI Combined With Bevacizumab and Intrathecal Chemotherapy in Advanced NSCLC Patients With Progressive Leptomeningeal Metastasis After Prior Standard-dose Third-generation EGFR-TKI Treatment.

Conditions
Leptomeningeal MetastasisLung Neoplasms, Non-Small Cell Lung Cancer
Other Study IDs
  • IIT-2025-640
NCT ID Number
NCT07398599
Start Date (Actual)
2026-02-15
Last Update Posted
2026-02-10
Completion Date (Estimated)
2027-12-30
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Leptomeningeal Metastasis
non-small cell lung cancer
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentala combined regimen consisting of double-dose third-generation EGFR-TKI, bevacizumab, and intrathecal
a combined regimen consisting of double-dose third-generation EGFR-TKI, bevacizumab, and intrathecal chemotherapy in patients
The combined treatment includes three components: double-dose third-generation EGFR-TKI (oral osimertinib 160mg once daily, furmonertinib 160mg once daily, or almonertinib 220mg once daily); intrathecal pemetrexed (administered via lumbar puncture, Ommaya reservoir, or intrathecal pump, with induction phase: 10mg twice weekly for 4 weeks, maintenance phase: 10mg once weekly for 4 weeks, consolidation phase: 30mg ever...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
LM-ORR
The primary endpoint is leptomeningeal metastasis overall response rate (LM-ORR) evaluated by RANO-LM criteria.
Up to 30 days after the last study drug administration (for safety and response assessment), and through study completion, an average of 1 years (for survival follow-up)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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 × 10^9/L; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; creatinine clearance ≥ 50 ml/min (for patients with liver metastases, TBIL ≤ 3.0 × ULN, ALT and AST ≤ 5.0 × ULN); activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤ 1.5 × ULN.
  • 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 administration.
  • 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) > 470 ms on consecutive electrocardiograms.
  • 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.
Second Affiliated Hospital of Nanchang University logoSecond Affiliated Hospital of Nanchang University
Study Central Contact
Contact: jing cai Jing Cai, 15270905381, [email protected]
1 Study Locations in 1 Countries

Jiangxi

The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Recruiting