RecruitingPhase 1/2

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

China15 participantsStarted 2026-05-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Complete blood count: absolute neutrophil count (ANC) \>=1.5 x 10\^9/L (1500/mm\^3), platelets \>=75 x 10\^9/L, hemoglobin \>=9 g/dL (if bone marrow is involved, platelets \>=50 x 10\^9/L, ANC \>=1.0 x 10\^9/L and hemoglobin \>=8 g/dL).
. Liver function: serum bilirubin \<=1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<=1.5 x ULN (if there is liver involvement, AST and ALT \<=5 x ULN are allowed).
. Renal function: serum creatinine \<=1.5 x ULN.
. Coagulation function: INR \<=1.5 x ULN; PT and APTT \<=1.5 x ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant treatment at screening).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0"

Timeframe: 2 year

Trial details

NCT IDNCT07744529

SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-28

Contact for this trial

Bicheng Zhang

86+15067126742 bicheng_zhang@zju.edu.cn

View on ClinicalTrials.gov More Leptomeningeal Metastasis From Lung Cancer trials