Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC

NCT05813522 | Unknown Phase 2

• 1 other identifier: CHNFLM-IIT-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Leptomeningeal Metastases; EGFR mutations; Furmonertinib; ctDNA

Outcome Measures

Primary Outcomes (2)

• 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.

  Assessed up to 12 months.

• 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.

  Assessed up to 12 months.

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Assessed up to 12 months.

• Disease Control Rate (DCR)

  Assessed up to 12 months.

• Overall Survival (OS)

  Assessed up to 24 months.

Other Outcomes (1)

• Adverse events/Serious adverse events

  From signing ICF to 30 days after the end of treatment.

Study Arms (1)

Furmonertinib

EXPERIMENTAL

Furmonertinib 160mg po qd

Drug: Furmonertinib Mesilate Tablets

Interventions

Furmonertinib Mesilate Tablets DRUG

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

Also known as: AST2818

Furmonertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Meningeal Carcinomatosis

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases

Study Officials

• Yuehong Wang

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: April 15, 2022
• Primary Completion: April 30, 2025
• Study Completion: August 31, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)