What is this study of pemetrexed and bevacizumab studying for leptomeningeal metastases in NSCLC?

This study is evaluating the safety and effectiveness of intrathecal injections of pemetrexed combined with bevacizumab in patients with leptomeningeal metastases from non-small cell lung cancer. Researchers want to understand how well this treatment works and its tolerability. The study is led by Shanghai Chest Hospital and aims to provide new options for patients with this serious condition.

Who may be eligible for this leptomeningeal metastases clinical trial?

Adults aged 18 years or older with diagnosed non-small cell lung cancer and leptomeningeal metastases may be eligible. Participants should have an ECOG performance status between 0 and 3, with higher scores due to this condition, and must not have previously received intrathecal pemetrexed or bevacizumab. Please review eligibility criteria for more details.

Is there any cost to participate in this leptomeningeal metastases clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other related costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID06663306

Efficacy and Safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC

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

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining two drugs, pemetrexed and bevacizumab, delivered directly into the spinal fluid for patients with leptomeningeal metastases caused by non-small cell lung cancer NSCLC. This phase Ia clinical study aims to gather early data on how well this treatment works and its safety in this specific group of cancer patients who have limited options due to cancer spread in the brain and spinal cord membranes. Participants receive intrathecal injections of pemetrexed twice a week for one week, then once every four weeks. Bevacizumab is given once during the first week with gradually increasing doses, then once every four weeks afterward. The study has two treatment groups one receiving pemetrexed alone and the other receiving both pemetrexed and bevacizumab. This approach allows researchers to compare the combination treatment with pemetrexed alone. During the study, patients will be monitored for side effects and treatment safety from the start of treatment until two months after. Researchers will also track overall survival for up to two years. Participants will undergo regular evaluations including clinical assessments, laboratory tests, and imaging as needed. The total duration and follow-up depend on individual patient progress, with safety and effectiveness carefully observed throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

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
Pathologically confirmed non-small cell lung cancer with leptomeningeal metastases diagnosed by cerebrospinal fluid analysis and/or MRI
Disease progression or neurological worsening of leptomeningeal metastases despite standard systemic anti-tumor treatment
Expected survival time of at least 1 month
Laboratory tests showing hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L; total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 2.5 times the upper limit of normal; creatinine ≤ 2.0 times the 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, 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
Ability to understand and sign the informed consent form

You will not qualify if you...

Positive for human immunodeficiency virus (HIV)
Allergy to pemetrexed or bevacizumab
Previous intrathecal injection of pemetrexed and/or bevacizumab
Contraindications to bevacizumab including uncontrolled hypertension, significant proteinuria, unstable angina, recent myocardial infarction, severe heart or vascular disease, major hemoptysis within the past month, coagulation disorders, serious non-healing wounds or ulcers, abdominal fistula or gastrointestinal perforation, macrovascular invasion, or certain neurological disorders unrelated to tumors
Brain or spinal cord radiation therapy within 1 week before enrollment
Pregnant or lactating females
Refusal to use contraception during the study period
Any condition considered unsuitable for enrollment by the investigator

Research Team

Hua Zhong, MD

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