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Non Small Cell Lung CancerPhase 2NCT05813522

Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC

A Phase 2 study testing Furmonertinib Mesilate Tablets in people with Non Small Cell Lung Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the clinical efficacy and safety of Furmonertinib in EGFR mutated NSCLC patients with leptomeningeal metastasis and to explore the feasibility of CSF ctDNA detection for efficacy evaluation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Furmonertinib Mesilate Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
15 Apr 2022to 31 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures.
  • Age ≥18 years.
  • Newly diagnosed NSCLC patients with leptomeningeal metastases associated with EGFR activating mutant or patients who develop leptomeningeal metastases only after treatment with first- or second-generation of EGFR-TKIs.
  • LM diagnosis was based on the detection of malignant cells in the CSF. Patients with new neurological symptoms and signs or typical MRI findings, together with the EGFR mutations detected by CSF ctDNA, can also be enrolled even if CSF cytology is not positive.
  • Subjects may be eligible for or have had CNS shunt or Ommaya fluid reservoir implantation. Patients who do not meet the requirements should be able to cooperate with lumbar puncture.
  • ECOG performance status of 0 to 2.
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  • Life expectancy ≥ 3 months.
  • Patients must have stable extracranial symptoms and have no CNS complications requiring urgent neurosurgical intervention for at least 4 weeks before study enrollment.
  • At least one measurable extracranial lesion as defined by RECIST 1.1.
  • Women of childbearing age (WOCBP) and male subjects should take effective contraception during the treatment and within 3 months after the end of treatment. WOCBP should be non-pregnant within 1 week prior to study enrollment.

Who cannot join

  • Previous or current treatment of any third-generation EGFR-TKI.
  • Previously treated with radiotherapy for central nervous system metastases.
  • A history of stroke within 6 months or pre-existing central nervous system damage which can interfere with neurological evaluation.
  • A history of chronic gastrointestinal disease or any other medical condition that would preclude adequate absorption of Furmonertinib.
  • Currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of Furmonertinib) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A4/5.
  • A history of previous or current tumors other than NSCLC, with the exception of radical non-melanoma skin cancer, carcinoma in situ of the cervix, benign prostate tumor/hypertrophy, or other cancers that have been radical and have no evidence of relapse for at least 5 years.
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  • Past medical history of any kinds of interstitial lung disease or radiation pneumonitis.
  • Systemic antitumor therapy with other agents was planned before enrollment or during the duration of the study.
  • Major surgery procedure or significant traumatic injury within 2 weeks of the first dose of study treatment.
  • A history of hypersensitivity reactions to the study medicine.
  • Peripheral neuropathy,greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment.
  • Any evidence of severe or uncontrolled serosal effusion and systemic diseases, including uncontrolled hypertension, diabetes, cardiovascular disease, active bleeding diatheses and severe acute or chronic infections that require systemic treatment(including positive HbsAg or positive HCV antibodies or confirmed positive HIV test result).
  • Inadequate bone marrow reserve or organ function.
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: Efficacy and Safety Analysis of Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC，Guiding by Cerebrospinal Fluid ctDNA Detection

The goal of this clinical trial is to evaluate the clinical efficacy and safety of Furmonertinib in EGFR mutated NSCLC patients with leptomeningeal metastasis and to explore the feasibility of CSF ctDNA detection for efficacy evaluation. Participants will be treated with 160mg Furmonertinib daily and tumor evaluation will be performed every 6-8 weeks. The participants' blood and cerebrospinal fluid samples will be collected three times during the study for ctDNA detection.

Read the detailed description

Advanced non-small cell lung cancer patients with leptomeningeal metastases tend to have a worse prognosis. Currently, no standard therapeutic regimen for LM has been established because of its rarity and heterogeneity. Targeted therapy is the primary treatment of patients with EGFRm of NSCLC. The drug concentration in cerebrospinal fluid is the key factors affecting the curative effect of intracranial metastatic lesions. The widespread application of EGFR-TKIs in clinical practice has significantly prolonged the survival period of patients with EGFR mutations, but the standard dose of first- and second-generation EGFR-TKIs show poor control of intracranial metastasis.Furmonertinib is a third-generation EGFR-TKI targeting both sensitising EGFR and EGFR T790M mutations. Phase 2 clinical study of furmonertinib revealed that furmonertinib was clinically effective with acceptable toxicity in patients with EGFR T790M mutated advanced NSCLC, including in patients with CNS metastases. At present, some study has found that the dynamic changes of EGFR in plasma ctDNA can be used to evaluate the prognosis of NSCLC patients. Some study has also observed that the copy number variations in CSF ctDNA of NSCLC patients with LM are related to the curative effect. Therefore, CSF ctDNA may become a new biomarker to assess the therapeutic effect of LM. This is a single-center, open, single-arm, exploratory phase 2 trial evaluating the clinical efficacy and safety of Furmonertinib in EGFR mutated NSCLC patients with leptomeningeal metastasis and to explore the feasibility of CSF ctDNA detection for efficacy evaluation.

Being tested
Furmonertinib Mesilate Tablets
Keywords
Non Small Cell Lung Cancer, Leptomeningeal Metastases, EGFR mutations, Furmonertinib, ctDNA
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.

  • Furmonertinib Mesilate TabletsDrug

    Also called AST2818

    160mg of Furmonertinib mesilate tablets (given as four 40mg tablets) administered orally once daily

Study groups in NCT05813522
Study groupRoleWhat they receive
FurmonertinibExperimentalFurmonertinib 160mg po qd
Receives: Drug: Furmonertinib Mesilate Tablets

What is being measured

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

  1. Intracranial Progression-Free Survival (PFSi)

    PFSi is defined as the time from first dose of Furmonertinib in this study until the date of intracranial disease progression.

    Measured: Assessed up to 12 months.

  2. Overall Progression-Free Survival (PFSo)

    PFSo is defined as the time from first dose of Furmonertinib in this study until the date of disease progression.

    Measured: Assessed up to 12 months.

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients with a best response of CR (complete response) or PR (partial response).

    Measured: Assessed up to 12 months.

  2. Disease Control Rate (DCR)

    DCR is defined as the proportion of patients with a best overall, extracranial and CNS, respectively, response of confirmed CR, confirmed PR, or SD.

    Measured: Assessed up to 12 months.

  3. Overall Survival (OS)

    OS is defined as the time from the date of first dose of Furmonertinib in this study until death due to any cause.

    Measured: Assessed up to 24 months.

Timeline

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

  1. First posted14 Apr 2023
  2. Study start15 Apr 2022
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion31 Aug 2025 (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
NCT05813522
Sponsor's protocol ID
CHNFLM-IIT-01
Status last verified
Apr 2023
First submitted
3 Apr 2023
Last updated
14 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share participant data of the trial.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Furmonertinib Mesilate Tablets in people with Non Small Cell Lung Cancer, run by First Affiliated Hospital of Zhejiang University 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 10 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial Progression-Free Survival (PFSi) (time frame: Assessed up to 12 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 NCT05813522.

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 14 Apr 2023.

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