Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06663306

Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC

Led by Shanghai Chest Hospital · Updated on 2026-03-02

19

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

Sponsors

S

Shanghai Chest Hospital

Lead Sponsor

I

Innovent Biologics (Suzhou) Co. Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.

CONDITIONS

Official Title

Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ECOG performance status score between 0 and 3, with scores of 2 or 3 due to leptomeningeal metastases
  • Pathological diagnosis of non-small cell lung cancer with cerebrospinal fluid and/or MRI confirmation of leptomeningeal metastasis
  • Disease progression or neurological worsening of leptomeningeal metastases despite standard systemic anti-tumor treatment
  • Expected survival time of at least 1 month
  • Laboratory tests meeting: Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L; total bilirubin ≤ 1.5 times upper limit of normal; ALT and AST ≤ 2.5 times upper limit of normal; creatinine ≤ 2.0 times upper limit of normal or creatinine clearance ≥ 50 mL/min
  • Females of child-bearing potential must agree to use contraception during the study and for 6 months after study completion, have a negative pregnancy test within 7 days before enrollment, and not be breastfeeding
  • Males must agree to use contraception during the study and for 6 months after study completion
  • Ability to understand and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Positive test for human immunodeficiency virus (HIV)
  • History of allergy to pemetrexed or bevacizumab
  • Previous intrathecal injection of pemetrexed and/or bevacizumab
  • Contraindications to bevacizumab, including uncontrolled hypertension (systolic ≥ 150 mmHg or diastolic ≥ 100 mmHg), history of hypertensive crisis or encephalopathy
  • Urine protein ≥ 2+ or 24-hour urine protein ≥ 2 g
  • Unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months, severe vascular disease, or uncontrolled arrhythmia
  • Major hemoptysis within the past month or history of coagulation disorders
  • Serious non-healing wounds, ulcers, or bone fractures
  • Abdominal fistula, gastrointestinal perforation, or gastrointestinal obstruction
  • Macrovascular invasion
  • Neurological disorders unrelated to tumors such as intracranial infection, cerebral hemorrhage, cerebral infarction, or encephalitis
  • Brain or spinal cord radiation therapy within 1 week prior to enrollment
  • Pregnant or breastfeeding women
  • Refusal to use contraception during the study period
  • Any condition deemed unsuitable for enrollment by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Chest Hospital

Shanghai, China, 200030

Actively Recruiting

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Research Team

H

Hua Zhong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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