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Leptomeningeal Metastasis From Lung CancerPhase 1/2NCT07559097

Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer

A Phase 1/2 study testing Methotrexate-loaded vesicles in people with Leptomeningeal Metastasis From Lung Cancer, run by Henan Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase I/II, single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of methotrexate-loaded autologous tumor cell-derived microparticles (MTX-MPs) in patients with leptomeningeal metastasis from lung cancer who have failed… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Methotrexate-loaded vesicles
Type of treatment
Injection or infusion
How many people
14 participants
Where
1 siteChina
Study dates
8 Sep 2025to 31 Dec 2027
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • Participants can be enrolled in this study only if they meet all of the following inclusion criteria:
  • Age ≥ 18 years old;
  • Diagnosed with lung cancer by pathological biopsy or cytology;
  • Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology;
  • Patients with advanced lung cancer and meningeal metastasis who have failed standard treatment;
  • ECOG PS 0 - 3.

Who cannot join

  • -
  • The following conditions will disqualify a patient from participating in this study:
  • Concurrent central nervous system infectious diseases;
  • ECOG PS ≥ 4;
  • Patients currently participating in other interventional studies;
  • History of or current severe immunodeficiency diseases;
  • Any other conditions that, in the judgment of the researcher, make the patient unfit to participate in this study.

Trial locations and contacts

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

China1 site, 1 recruiting

  • Wang Qiming

    Zhengzhou, Henan, 450000

    Wang Qiming, PhD, 037165588421, qimingwang1006@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II, Single-arm, Single-center Clinical Study: Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer

This is a phase I/II, single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of methotrexate-loaded autologous tumor cell-derived microparticles (MTX-MPs) in patients with leptomeningeal metastasis from lung cancer who have failed standard of care.

The study consists of two phases: Phase I employs an accelerated titration combined with a "3+3" dose-escalation design to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Phase II further assesses the objective response rate (ORR) at the RP2D. Key secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profile.

Read more

Approximately 10-20 patients with cytologically confirmed leptomeningeal metastasis (age ≥18 years, ECOG PS 0-3) will be enrolled. Participants will receive intrathecal MTX-MPs on days 1, 3, and 5 of the first cycle, followed by once every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or death.

Tumor response will be evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria for leptomeningeal metastasis, and adverse events will be graded according to CTCAE version 5.0. This exploratory study may provide a novel local therapeutic approach for leptomeningeal metastasis from lung cancer.

Being tested
Methotrexate-loaded vesicles

What participants receive

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

  • Methotrexate-loaded vesiclesBiological

    Intrathecal injection of methotrexate-loaded vesicles

What is being measured

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

  1. Phase I: Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D)

    Phase I: To determine the MTD and RP2D using an accelerated titration plus 3+3 dose-escalation design.

    Measured: Expected for 15 months

  2. Phase II:Objective Response Rate(ORR)

    Phase II: Objective Response Rate (ORR) per RANO criteria for leptomeningeal metastasis, defined as the proportion of patients achieving complete response (CR) or partial response (PR).

    Measured: Expected for 15 months

Secondary outcomes (3)

  1. Safety and Tolerability

    Incidence, severity, and causality of adverse events (AEs) graded by CTCAE v5.0, including acute reactions within 3 days after each intrathecal injection, neurological toxicities, and laboratory abnormalities.

    Measured: From first dose up to 30 days after last dose (or study completion)

  2. Progression-Free Survival (PFS)

    Time from first dose of study drug to first documented disease progression per RANO criteria for leptomeningeal metastasis, or death from any cause, whichever occurs first.

    Measured: From first dose up to approximately 15 months

  3. Overall Survival (OS)

    Time from first dose of study drug to death from any cause.

    Measured: From first dose up to approximately 27 months.

Timeline

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

  1. First posted30 Apr 2026
  2. Study start8 Sep 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07559097
Sponsor's protocol ID
2024-386
Status last verified
Apr 2026
First submitted
24 Apr 2026
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hyun JW, Jeong IH, Joung A, Cho HJ, Kim SH, Kim HJ. Leptomeningeal metastasis: Clinical experience of 519 cases. Eur J Cancer. 2016 Mar;56:107-114. doi: 10.1016/j.ejca.2015.12.021. Epub 2016 Feb 1.

    PubMed 26841095

  • Remon J, Le Rhun E, Besse B. Leptomeningeal carcinomatosis in non-small cell lung cancer patients: A continuing challenge in the personalized treatment era. Cancer Treat Rev. 2017 Feb;53:128-137. doi: 10.1016/j.ctrv.2016.12.006. Epub 2016 Dec 30.

    PubMed 28110254

  • Cheng H, Perez-Soler R. Leptomeningeal metastases in non-small-cell lung cancer. Lancet Oncol. 2018 Jan;19(1):e43-e55. doi: 10.1016/S1470-2045(17)30689-7.

    PubMed 29304362

  • Eichler AF, Kahle KT, Wang DL, Joshi VA, Willers H, Engelman JA, Lynch TJ, Sequist LV. EGFR mutation status and survival after diagnosis of brain metastasis in nonsmall cell lung cancer. Neuro Oncol. 2010 Nov;12(11):1193-9. doi: 10.1093/neuonc/noq076. Epub 2010 Jul 13.

    PubMed 20627894

  • Solar P, Zamani A, Kubickova L, Dubovy P, Joukal M. Choroid plexus and the blood-cerebrospinal fluid barrier in disease. Fluids Barriers CNS. 2020 May 6;17(1):35. doi: 10.1186/s12987-020-00196-2.

    PubMed 32375819

  • Leibold AT, Monaco GN, Dey M. The role of the immune system in brain metastasis. Curr Neurobiol. 2019 Jul;10(2):33-48.

    PubMed 31097897

  • Lukas RV, Thakkar JP, Cristofanilli M, Chandra S, Sosman JA, Patel JD, Kumthekar P, Stupp R, Lesniak MS. Leptomeningeal metastases: the future is now. J Neurooncol. 2022 Feb;156(3):443-452. doi: 10.1007/s11060-021-03924-2. Epub 2022 Jan 20.

    PubMed 35048267

  • Wang N, Bertalan MS, Brastianos PK. Leptomeningeal metastasis from systemic cancer: Review and update on management. Cancer. 2018 Jan 1;124(1):21-35. doi: 10.1002/cncr.30911. Epub 2017 Nov 22.

    PubMed 29165794

  • Yin K, Li YS, Zheng MM, Jiang BY, Li WF, Yang JJ, Tu HY, Zhou Q, Zhong WZ, Yang XN, Chen HJ, Yan HH, Li LL, Wu YL, Zhang XC. A molecular graded prognostic assessment (molGPA) model specific for estimating survival in lung cancer patients with leptomeningeal metastases. Lung Cancer. 2019 May;131:134-138. doi: 10.1016/j.lungcan.2019.03.015. Epub 2019 Mar 18.

    PubMed 31027690

  • Wu YL, Zhou L, Lu Y. Intrathecal chemotherapy as a treatment for leptomeningeal metastasis of non-small cell lung cancer: A pooled analysis. Oncol Lett. 2016 Aug;12(2):1301-1314. doi: 10.3892/ol.2016.4783. Epub 2016 Jun 24.

    PubMed 27446430

  • Gwak HS, Joo J, Kim S, Yoo H, Shin SH, Han JY, Kim HT, Lee JS, Lee SH. Analysis of treatment outcomes of intraventricular chemotherapy in 105 patients for leptomeningeal carcinomatosis from non-small-cell lung cancer. J Thorac Oncol. 2013 May;8(5):599-605. doi: 10.1097/JTO.0b013e318287c943.

    PubMed 23422833

  • Morris PG, Reiner AS, Szenberg OR, Clarke JL, Panageas KS, Perez HR, Kris MG, Chan TA, DeAngelis LM, Omuro AM. Leptomeningeal metastasis from non-small cell lung cancer: survival and the impact of whole brain radiotherapy. J Thorac Oncol. 2012 Feb;7(2):382-5. doi: 10.1097/JTO.0b013e3182398e4f.

    PubMed 22089116

  • Liang Q, Bie N, Yong T, Tang K, Shi X, Wei Z, Jia H, Zhang X, Zhao H, Huang W, Gan L, Huang B, Yang X. The softness of tumour-cell-derived microparticles regulates their drug-delivery efficiency. Nat Biomed Eng. 2019 Sep;3(9):729-740. doi: 10.1038/s41551-019-0405-4. Epub 2019 May 20.

    PubMed 31110292

  • Guo M, Wu F, Hu G, Chen L, Xu J, Xu P, Wang X, Li Y, Liu S, Zhang S, Huang Q, Fan J, Lv Z, Zhou M, Duan L, Liao T, Yang G, Tang K, Liu B, Liao X, Tao X, Jin Y. Autologous tumor cell-derived microparticle-based targeted chemotherapy in lung cancer patients with malignant pleural effusion. Sci Transl Med. 2019 Jan 9;11(474):eaat5690. doi: 10.1126/scitranslmed.aat5690.

    PubMed 30626714

  • Dong X, Huang Y, Yi T, Hu C, Gao Q, Chen Y, Zhang J, Chen J, Liu L, Meng R, Zhang S, Dai X, Fei S, Jin Y, Yin P, Hu Y, Wu G. Intrapleural infusion of tumor cell-derived microparticles packaging methotrexate or saline combined with pemetrexed-cisplatin chemotherapy for the treatment of malignant pleural effusion in advanced non-squamous non-small cell lung cancer: A double-blind, randomized, placebo-controlled study. Front Immunol. 2022 Oct 5;13:1002938. doi: 10.3389/fimmu.2022.1002938. eCollection 2022.

    PubMed 36275698

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Methotrexate-loaded vesicles in people with Leptomeningeal Metastasis From Lung Cancer, run by Henan Cancer 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Apr 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) (time frame: Expected for 15 months). The study lists 2 primary outcomes in all. 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 NCT07559097, which also lists 18 linked publications.

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 30 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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