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Leptomeningeal MetastasisPhase 2LEP-THP-2026NCT07778940

Thiotepa Administration Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI.

A Phase 2 study testing Thiotepa in people with Leptomeningeal Metastasis, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if the Thiotepa administration via Ommaya Reservoir works to treat non-small cell lung cancer with leptomeningeal metastases resistant to EGFR TKI. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Leptomeningeal Metastasis
What is being tested?
Thiotepa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Sep 2026to Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 years.
  • Male or female of non-childbearing potential, or female of childbearing potential who is not pregnant or lactating.
  • ECOG performance status of 0 to 2, with no deterioration within the past 7 days.
  • Radiological and/or cerebrospinal fluid (CSF) cytological evidence of leptomeningeal metastases (LM). The diagnosis of non-small cell lung cancer (NSCLC) must be confirmed by histological and/or cytological examination.
  • Patients must meet at least one of the following criteria: failure of first- or second-generation TKI therapy with T790M mutation negative; failure of third-generation TKI therapy; or EGFR mutation negative with failure of first-line therapy.
  • If concurrent brain parenchymal metastases are present, they must have received appropriate treatment or been evaluated as stable over the past three months. Additionally, extracranial lesions must be evaluated as stable under the current treatment regimen.
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  • Adequate organ and bone marrow function, as evidenced by the following laboratory parameters: HGB ≥ 90 g/L; NEUT ≥ 1.5 × 10⁹/L; PLT ≥ 80 × 10⁹/L; TBIL ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN (if liver metastases are present, ALT and AST ≤ 5 × ULN); creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula); urine protein < (++) or 24-hour urine protein < 1.0 g; normal coagulation function without active bleeding; INR ≤ 1.5; APTT ≤ 1.5 × ULN.
  • Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must voluntarily use adequate contraception during the study period and for 8 weeks after the last dose of the study drug. Males must be surgically sterilized or agree to use adequate contraception during the study period and for 8 weeks after the last dose of the study drug.
  • Prior Ommaya reservoir implantation.
  • Estimated life expectancy of ≥ 12 weeks.
  • No history of severe neurological diseases or severe hematological abnormalities.
  • Patients who have received prior brain and/or spinal cord radiotherapy, including stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT), are eligible, provided that radiotherapy was completed at least 7 days prior to the initiation of study treatment.
  • Concurrent intrathecal therapy with other agents is prohibited. For patients who have received other systemic therapies, the minimum washout periods are as follows: patients who have received prior intrathecal therapy must complete the last treatment at least 7 days before initiating study treatment; patients who have received systemic chemotherapy must complete the last treatment at least 14 days before initiating study treatment; patients who have received approved systemic immunotherapy (e.g., anti-PD-1, anti-CTLA-4) must complete the last treatment at least 14 days before initiating study treatment; patients who have received any other investigational drugs must complete the last treatment at least 14 days before initiating study treatment.
  • Ability to provide written informed consent, including compliance with the requirements and restrictions listed in the informed consent form. Patients must have good compliance, voluntarily agree to participate in the clinical study, sign the informed consent form, and be willing to cooperate with follow-up visits.

Who cannot join

  • Patients requiring ventriculoperitoneal (VP) shunt placement due to elevated intracranial pressure.
  • History of epilepsy unrelated to leptomeningeal metastases.
  • Evidence of any neurological functional failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy as shown on imaging, or a Glasgow Coma Scale (GCS) score < 11.
  • Evidence of any extensive and fatal progressive systemic disease with no effective treatment available.
  • Prior allogeneic bone marrow transplantation or solid organ transplantation. Uncontrolled hypertension prior to enrollment, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
  • Surgical procedures involving vital organs within 3 months prior to enrollment.
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  • Any disease or condition prior to enrollment that affects drug absorption. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) classification > Grade 2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) < 50%; or other related diseases such as severe pulmonary, hepatic, or renal dysfunction, severe gastrointestinal ulcers, or coagulation dysfunction.
  • Active or uncontrolled severe infections (≥ Grade 2 infections per CTCAE v5.0).
  • Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must be excluded if they have active HBV infection, defined as HBV DNA positive (>1×10⁴ copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection with HCV RNA positive (>1×10³ copies/mL)].
  • Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities that, in the investigator's judgment, provide reason to suspect a disease or condition that makes the patient unsuitable for the study drug (e.g., seizures requiring treatment), will affect the interpretation of study results, or place the patient at high risk.
  • Patients with a prior history of basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancers may be considered for enrollment if there is evidence of being disease-free for more than 5 years after treatment.
  • Severe neurological or psychiatric history; active disseminated intravascular coagulation (DIC); or other concomitant diseases that, in the investigator's judgment, seriously jeopardize patient safety or affect the patient's ability to complete the study.
  • Participation in other clinical trials, receipt of investigational drugs, or any concomitant treatments containing investigational drugs within 14 days prior to enrollment.
  • Patients deemed unsuitable for this study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chunhua She contact

022-23340123 ext. 1041

shechunhua@tmu.edu.cn

China1 site

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Chunhua She, 022-23340123 ext. 1041, shechunhua@tmu.edu.cn

Other trials in China

About this study

Official title: A Single-Arm Phase II Study of Intrathecal Thiotepa Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI

The goal of this clinical trial is to learn if the Thiotepa administration via Ommaya Reservoir works to treat non-small cell lung cancer with leptomeningeal metastases resistant to EGFR TKI. The main questions to answer are:

Is Thiotepa administration via Ommaya Reservoir safe to inject? How effective is thiotepa via Ommaya Reservoir in intracranial-disease control? Participants will：

Stage 1: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, twice every week, for 4 consecutive weeks; Stage 2: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, once every week, for 4 consecutive weeks; Stage 3: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, once a month, for 4 consecutive months; Before each intrathecal administration, a preliminary intrathecal injection of dexamethasone, 2.5 mg/dose, is given.

Being tested
Thiotepa
Medical subject headings
Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThiotepaDrug

    thiotepa administration via Ommaya reservoir

Study groups in NCT07778940
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Drug: Thiotepa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial Objective Response Rate(iORR)

    Measured: 1-year

Secondary outcomes (1)

  1. Intracranial Progression-Free Survival

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07778940
Sponsor's protocol ID
E20260975
Acronym
LEP-THP-2026
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
21 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Thiotepa in people with Leptomeningeal Metastasis, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chunhua She (022-23340123 ext. 1041, shechunhua@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial Objective Response Rate(iORR) (time frame: 1-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07778940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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