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Amivantamab Combined With Intrathecal Pemetrexed for LM From EGFR-Mutated Lung Adenocarcinoma

NCT07744529 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether amivantamab combined with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung adenocarcinoma. Leptomeningeal metastasis occurs when cancer cells spread to the membranes surrounding the brain and spinal cord or to the cerebrospinal fluid. It is a serious complication of advanced lung cancer and is difficult to treat because many systemic drugs do not reach high enough levels in the cerebrospinal fluid.

The main questions this study aims to answer are:

What medical problems do participants have when receiving amivantamab combined with intrathecal pemetrexed? How long do participants live without their disease getting worse after receiving this treatment? How long do participants survive after starting this treatment?

Participants will:

Receive amivantamab by intravenous infusion according to the study schedule. Receive intrathecal pemetrexed, together with dexamethasone and normal saline, once every week.

Continue their original EGFR tyrosine kinase inhibitor treatment as determined by the study doctor.

Have cerebrospinal fluid pressure measured and cerebrospinal fluid samples collected before each intrathecal treatment.

Have tests of cerebrospinal fluid, including routine tests, biochemical tests, tumor markers, albumin, IgG, and cytology.

Have imaging tests, including enhanced MRI, about every 3 months to check the disease.

Be followed by clinic visits and/or telephone calls to collect information about survival, disease status, side effects, and any later cancer treatments.

Conditions

  • Leptomeningeal Metastasis From Lung Cancer

Interventions

DRUG

Amivantamab+ systemic/ intrathecal Pemetrexed

Amivantamab dosing regimen: once weekly in the first month, 350 mg each time; no dosing is required in weeks 5 and 6. Starting from week 7, 700 mg each time once every 3 weeks. Systemic pemetrexed dosing regimen: day 1 of week 1, week 4, week 7 and once every 3 weeks thereafter, 500 mg/m2. Intrathecal injection shall be performed by personnel qualified to perform intrathecal injection (personnel of the Department of Radiation Oncology of our hospital holding standardized residency training certificates).

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-28
Primary Completion
2028-05-28
Completion
2028-05-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744529 on ClinicalTrials.gov