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Spinal fluid chemo cocktail targets tough brain cancer spread

NCT ID NCT06663306

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether injecting two cancer drugs (pemetrexed and bevacizumab) directly into the spinal fluid is safe for people with a specific type of lung cancer that has spread to the lining of the brain. The trial will enroll 19 adults whose cancer has worsened despite standard treatment. The main goal is to check for side effects, but researchers will also track how long participants live.

What this could mean

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

Active substance
pemetrexed and bevacizumab
What this could lead to
If it works, this could point toward a new treatment option for lung cancer that has spread to the lining of the brain, a condition with very few options.
What could go wrong
This is a very early phase 1 trial with only 19 people, so it is primarily testing safety, not effectiveness. The drugs are given directly into the spinal fluid, which carries risks like infection or nerve damage.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 19 people

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

Started

Dec 2024

Expected to finish

Dec 2027

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: * Age ≥ 18 years; * ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases. * Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis(LM); * Unsatisfactory efficacy of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received standard systemic anti-tumor treatment; * Expected survival time ≥ 1 month; * The laboratory test results meet the following criteria: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 (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN ; Creatinine≤ 2.0 × ULN,or Creatinine clearance rate (CrCl) ≥ 50 mL/min; * Females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study; * Understand and sign the informed consent form. Exclusion Criteria: * Positive for human immunodeficiency virus (HIV) ; * History of allergy to pemetrexed or bevacizumab; * History of pemetrexed and/or bevacizumab intrathecal Injection; * Presence of contraindication of bevacizumab: 1. Uncontrolled hypertension(systolic pressure≥150mmHg,or diastolic pressure≥100mmHg;History of hypertensive crisis or hypertensive encephalopathy; 2. Urine protein≥2+,or 24-hour urine protein≥2g; 3. Unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia; 4. Major hemoptysis within the past 1 month; History of coagulation disorders; 5. Presence of serious non-healing wounds, ulcers, or bone fractures 6. Presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction; 7. Presence of macrovascular invasion; 8. Some neurological disorders unrelated to tumors,such as intracranial infection,cerebral hemorrhage,cerebral infarction,encephalitis; * Brain/spinal cord radiation therapy within 1 week before enrollment; * Pregnant and lactating female; * Refuse to use contraception during the study period; * Individuals considered by the investigator to be unsuitable for enrollment.

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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

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, 200030, China

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