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

Sponsor
Shanghai Chest Hospital
Study ID
NCT06663306
Phase
PHASE1
Status
Recruiting
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Conditions

  • Leptomeningeal Metastasis
  • Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemetrexed — DRUG
    Intrathecal pemetrexed 50mg,twice per week (d1, d8) for 1 week, then once per 4 weeks
  • Bevacizumab — DRUG
    Intrathecal bevacizumab, once (d8)for 1 week, then once per 4 weeks.The initial dose of intrathecal bevacizumab is 5 mg, escalated to 10 mg, and then 25 mg, and then 37.5mg, and then 50mg.

Study Details

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.

Key Dates

First listed
Oct 29, 2024
Start date
Dec 9, 2024
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
19 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Enrolled patients were treated with pemetrexed intrathecal injection
  • Experimental: Arm B
    Enrolled patients were treated with pemetrexed combined with bevacizumab intrathecal injection

Primary Outcome Measure

Incidence of Adverse Events (Safety and Tolerability) [ Time Frame: From the beginning of the treatment until two months after the treatment. ]

Central Contacts

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