Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a Two-Drug attack reach cancer hiding in the brain?

NCT ID NCT07744529

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial is testing whether combining two drugs—amivantamab given intravenously and pemetrexed injected directly into the spinal fluid—can safely help people with a specific type of lung cancer that has spread to the membranes around the brain and spinal cord. This condition, called leptomeningeal metastasis, is hard to treat because many cancer drugs don't reach high enough levels in the spinal fluid. The study will include adults with EGFR-mutated lung adenocarcinoma and will monitor side effects, how long participants live without the disease worsening, and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amivantamab combined with intrathecal pemetrexed
What this could lead to
If successful, this combination could offer a new treatment option for a serious complication of lung cancer that is hard to treat because many drugs don't reach the brain and spinal cord.
What could go wrong
This is an early-phase, small study (15 participants), so results may not be conclusive. The treatment may cause side effects, and it's not yet known if it will improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntary participation in the clinical study: fully understands and is informed of this study and signs the written informed consent form; is willing and able to complete all trial procedures. * Age: \>=18 years; male or female. * Patients with EGFR-mutated lung adenocarcinoma with leptomeningeal metastasis diagnosed according to the EANO-ESMO guidelines. * Expected survival of at least 3 months. * Adequate organ and bone marrow function, with no severe hematopoietic abnormality and no severe cardiac, pulmonary, hepatic or renal dysfunction or immunodeficiency (within 14 days before use of study drug, no blood transfusion, granulocyte colony-stimulating factor or other relevant medical support): 1. 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). 2. 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). 3. Renal function: serum creatinine \<=1.5 x ULN. 4. 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). * Left ventricular ejection fraction (LVEF) in cardiac function examination \>=50%. * Negative serum pregnancy test, and effective contraception from signing the informed consent form until 6 months after the last chemotherapy dose. * Thyroid-stimulating hormone (TSH), free thyroxine (FT4) or free triiodothyronine (FT3) within +/-10% of the normal range. * Ophthalmic examination, including dilated fundus examination, slit-lamp examination and color fundus photography. Exclusion Criteria: * Currently participating in another clinical study, or less than 4 weeks between the first dose of the study drug and the end of treatment in a previous clinical study. * History of other malignancies within the past 5 years. * Patients who have received CNS-directed prophylactic treatment. * Patients with known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. * Patients with active autoimmune disease or a history of autoimmune disease with a high risk of recurrence, including but not limited to immune-related neuropathy, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, inflammatory bowel cancer (including Crohn disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis or Stevens-Johnson syndrome. * Patients with active chronic hepatitis B or active hepatitis C. Patients who are positive for hepatitis B surface antigen or hepatitis C virus antibody during screening may be enrolled only after further HBV DNA titer testing (not higher than 1000 IU/mL) and HCV RNA testing (not exceeding the lower limit of detection of the assay), and after active hepatitis B or hepatitis C infection requiring treatment has been excluded. Hepatitis B virus carriers, patients with stable hepatitis B after drug treatment and patients with cured hepatitis C may be enrolled. * Active pulmonary tuberculosis. * Current interstitial lung disease or infectious pneumonia. * Active infection requiring systemic anti-infective therapy, including but not limited to bacterial, fungal or viral infection. * Within 6 months before screening, New York Heart Association (NYHA) class III or IV heart failure, unstable angina, severe poorly controlled ventricular arrhythmia, or electrocardiographic evidence of acute ischemia or myocardial infarction. * QTcF interval \>480 msec, unless secondary to bundle branch block. * Uncontrolled comorbid disease, including but not limited to uncontrolled hypertension, active peptic ulcer or bleeding disorder. * History of psychiatric illness; incapacity or limited capacity for civil conduct. * In the judgment of the investigator, the patient's underlying condition may increase the risk of receiving study drug treatment or confound the occurrence and assessment of toxic reactions. * Other patients whom the investigator considers unsuitable for participation in this study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Leptomeningeal metastasis from lung cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital,School of Medicine,Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.