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Non Small Cell Lung CancerPhase 2NCT07304739

Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases

A Phase 2 study testing Furmonertinib, Intrathecal chemotherapy and Stereotactic radiotherapy in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 3 sites 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
Search all trials

Trial summary

A Single-Arm Clinical Study of Furmonertinib (160mg) Combined with Intrathecal Chemotherapy (ITC) and Stereotactic Radiotherapy (SRT) as First-Line Treatment in EGFR Classic Mutation-Positive NSCLC Patients with Brain Parenchymal and Leptomeningeal Metastases Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Furmonertinib, Intrathecal chemotherapy and Stereotactic radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesChina
Study dates
22 Dec 2025to 30 Dec 2029
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

  • 18 to 75 years old, male or female;
  • Histopathologically confirmed, unresectable, and not amenable to curative radiotherapy treatment-naïve locally advanced or metastatic lung adenocarcinoma;
  • The patient was confirmed by a local laboratory to have one of the following EGFR mutations :19Del or L858R;
  • The patient has not received any systemic anti-tumor treatment in the locally advanced (the researcher judged that it was not suitable for surgery or radiotherapy) or metastatic NSCLC;
  • At least one measurable tumor lesion (according to RECIST1.1);
  • Confirm the simultaneous presence of brain parenchymal and meningeal metastasis;
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  • Laboratory tests indicated that the subjects had adequate organ functions, including: 1) ANC ≥1.5×109/L; PLT ≥100×109/L; HGB ≥90g/L; 2) TBIL ≤1.5 times the upper limit of the normal value, AST and ALT ≤2.5 times the upper limit of the normal value (for those with liver metastasis, total bilirubin ≤ 3 times the upper limit of the normal value, AST and ALT≤ 5 times the upper limit of the normal value are allowed); 3) CrCL ≥50 ml/min (calculated according to the Cockcroft-Gault formula);
  • The ECOG score at the time of screening was 0-2, and there was no significant deterioration of the disease within 2 weeks before the screening;
  • The expected survival period is greater than 12 weeks;
  • Non-pregnant female patients of childbearing potential with no pregnancy plan. Female subjects of childbearing potential and male subjects must agree to use effective contraception during the study period and for 6 months after discontinuation of the study drug;
  • Understand and voluntarily participate in this study and sign the informed consent form.

Who cannot join

  • Histological or cytological examination suggests NSCLC dominated by squamous cells, or indicates the presence of small cell lung cancer, neuroendocrine carcinoma, etc.；
  • Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included；
  • Anticipated requirement for other antitumor therapies beyond this clinical trial during the study period;
  • Having received any of the following treatments: a) Major surgery within 4 weeks prior to the first dose or during the trial period, excluding procedures such as vascular access establishment, mediastinoscopy, or thoracoscopy for biopsy; b) Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days prior to the first dose; Use of Chinese herbal medicines or preparations with anti-tumor indications or those adjunctive to cancer therapy within 2 weeks prior to the first dose or expected during the trial period; c) Participation in an investigational drug or device clinical trial within 4 weeks or at least 5 half-lives (whichever is longer) prior to the first dose; d) Treatment with other antitumor drugs within 14 days prior to the first dose;
  • Patients with symptomatic and unstable pleural or peritoneal effusion; those who have achieved clinical stability for at least 14 days after drainage of pleural effusion or ascites may be enrolled;
  • Toxicities from prior antitumor therapy have not recovered to ≤ CTCAE grade 1(with the exception of alopecia and residual neurotoxicity from previous platinum-based therapy)；
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  • History of other malignancies or currently concurrent other malignancies (except for malignancies that have undergone radical resection with no recurrence within 5 years, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma);
  • History of interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring steroid treatment; or current clinical manifestations suggestive of ILD;
  • Severe or uncontrolled systemic diseases requiring treatment including hypertension, diabetes, chronic heart failure (NYHA class III-IV), unstable angina, myocardial infarction within the past year, active hemorrhagic conditions, severe gastrointestinal disorders, active infectious diseases, etc.;
  • Resting QT interval (QTc) > 470 msec as measured by clinical ECG screening; Clinically significant prolonged QT interval or other arrhythmias or clinical conditions that may increase the risk of QT prolongation;
  • Known history of psychiatric disorders or drug abuse, with current active symptoms or ongoing drug use;
  • Known or suspected hypersensitivity to furmonertinib or any excipients of its formulation;
  • Female subjects who are pregnant or breastfeeding, or female partners of male subjects who plan to become pregnant during the study period;
  • The subject demonstrated poor compliance;
  • Any other condition deemed by the investigator to make the subject unsuitable for participation in this study.

Trial locations and contacts

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

Maobin Meng, MD contact

+86 15202231270

mmeng@tmu.edu.cn

China3 sites, 3 recruiting

  • CANGZHOU People's Hospital

    Cangzhou, Hebei, 061001

    CANGZHOU People's Hospital, +86-0317-3521004, dzb3521000@163.com

    Jian Yang, MD

    Recruiting

  • Tianjin medical university cancer hospital and institute

    Tianjin, Tianjin Municipality, 300060

    Tianjin medical university cancer hospital and institute, 022-23340123-6417, ec_tjcih@126.com

    Maobin Meng, MD

    Recruiting

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300350

    Tianjin Huanhu Hospital, +86-13502135838, liuxiaomintj@126.com

    Xiaomin Liu, MD

    Recruiting

Other trials in China

About this study

Official title: A Single-Arm Clinical Study of Furmonertinib (160mg) Combined With Intrathecal Chemotherapy (ITC) and Stereotactic Radiotherapy (SRT) as First-Line Treatment in EGFR Classic Mutation-Positive NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases

A Single-Arm Clinical Study of Furmonertinib (160mg) Combined with Intrathecal Chemotherapy (ITC) and Stereotactic Radiotherapy (SRT) as First-Line Treatment in EGFR Classic Mutation-Positive NSCLC Patients with Brain Parenchymal and Leptomeningeal Metastases

Read the detailed description

The incidence of central nervous system (CNS) metastases in NSCLC representing a primary cause of mortality. In recent years, the widespread use of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) has significantly prolonged survival in lung adenocarcinoma patients, consequently leading to increased incidence of brain metastases (BM) and leptomeningeal metastases (LM). Both BM and LM are associated with poor prognosis. Therefore, developing more effective treatment strategies for BM and LM patients has become a cutting-edge, challenging, and critically important research focus.This study aims to evaluate the efficacy and safety of Furmonertinib (160 mg) combined with intrathecal chemotherapy and stereotactic radiotherapy (SRT) in treatment-naïve EGFR-mutated NSCLC patients with concurrent parenchymal brain and leptomeningeal metastases. The objective is to explore potential survival benefits for this poor-prognosis population and provide additional clinical treatment options.

Being tested
Furmonertinib, Intrathecal chemotherapy, Stereotactic radiotherapy
Keywords
NSCLC, EGFR mutation, Brain parenchymal and meningeal metastases, Furmonertinib, Intrathecal chemotherapy, Stereotactic radiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Meningeal Carcinomatosis

What participants receive

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

  • FurmonertinibDrug

    Furmonertinib: 160mg, once daily, orally.

  • Intrathecal chemotherapyDrug

    Intrathecal chemotherapy with 40mg of pemetrexed and 2mg of dexamethasone, every 3 weeks as one cycle.

  • Stereotactic radiotherapyRadiation

    After two cycles of intrathecal chemotherapy, there was no progression upon re-examination. The stereotactic radiotherapy (SRT) for brain metastases with 7-19Gy/1-5Fx.

Study groups in NCT07304739
Study groupRoleWhat they receive
Furmonertinib combined with intrathecal chemotherapy and stereotactic radiotherapy groupExperimentalNot described
Receives: Drug: Furmonertinib; Drug: Intrathecal chemotherapy; Radiation: Stereotactic radiotherapy

What is being measured

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

  1. iPFS

    iPFS is defined as the time from the start of treatment to the occurrence of intracranial disease progression (excluding non-intracranial progression) or death

    Measured: From enrollment to the occurrence of intracranial disease progression (excluding non-intracranial progression) or death，assessed up to 2 year

Secondary outcomes (5)

  1. PFS

    defined as the time from the start of treatment to the occurrence of objective tumor progression or all-cause death

    Measured: from the start of treatment to the occurrence of tumor progression or all-cause death, assessed up to 2 year

  2. OS

    Measured: from the start of treatment to death, 2 years

  3. LM remission rate

    Measured: Until the end of the study, 1year

  4. iORR

    The proportion of patients achieving a pre-specified reduction in intracranial lesion volume sustained for the minimum required duration (at least 4 weeks).

    Measured: From enrollment to the end of treatment at 1 year

  5. iDCR

    The proportion of subjects with intracranial lesions achieving disease control (including complete response [CR], partial response [PR], or stable disease [SD]) from the initiation of treatment.

    Measured: From enrollment to the end of treatment at 1year

Timeline

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

  1. First posted26 Dec 2025
  2. Study start22 Dec 2025 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2029 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07304739
Sponsor's protocol ID
E20250589
Status last verified
May 2025
First submitted
23 Sep 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Furmonertinib, Intrathecal chemotherapy and Stereotactic radiotherapy in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 3 sites 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 11 inclusion and 15 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Maobin Meng, MD (+86 15202231270, mmeng@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

iPFS (time frame: From enrollment to the occurrence of intracranial disease progression (excluding non-intracranial progression) or death，assessed up to 2 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 NCT07304739.

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 26 Dec 2025.

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