An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis

Recruiting

• Conditions: EGF-R Positive Non-Small Cell Lung Cancer; CNS Metastases
• Interventions: Drug: Furmonertinib

• Registration Number: NCT06352502
• Lead Sponsor: Tang-Du Hospital

Brief Summary

EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis.

Detailed Description

This study aims to prospectively observe the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis and will recruit about 30 patients in China.

Furmonertinib (AST2818) is a brain penetrant third generation EGFR TKI. In preclinical studies, the concentration of furmonertinib and its main active metabolite in the brain was higher than that in the plasma, indicating that furmonertinib had the potential to treat CNS metastases. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily in patients with EGFR T790M mutated NSCLC, the median CNS PFS was 11.6 months and 19.3 months in the 80 mg and 160 mg orally once daily group, and the CNS ORR was 65% and 85% in the 80 mg and 160 mg group.

This study will enroll the EGFR-sensitive mutation positive NSCLC patients with brain metastasis who are treated by furmonertinib, and the efficacy and safety data will be recorded.

Study Timeline

• Study Start: 2022-01-28
• Study First Submitted: 2024-03-07
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-08
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. at least 18 years of age;
2. Histologically or cytologically confirmed metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC);
3. Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.( EGFR L858R or Del 19 with/without T790M )
4. Imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation;
5. Organ function is compatible with oral Furmonertinib therapy (investigator determination based on real-world practice);
6. Life expectancy ≥12 weeks before Fumonertinib initiation;
7. ECOG PS of 0 to 2;
8. Sign the informed consent form.

Exclusion Criteria

1. Any Third-Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) before Furmonertinib initiation;
2. Known hypersensitivity to Furmonertinib or its excipient components;
3. Simultaneous systemic chemotherapy or WBI;
4. The time from the treatment with any other investigational product or its analogue before Furmonertinib initiation does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
5. Any evidence of severe or uncontrolled systemic diseases;
6. Presence of any disease that may strongly interfere with oral drug absorption; presence of any factor that contributes to QTc prolongation or increased risk of arrhythmia; presence of interstitial pneumonitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Furmonertinib group	Furmonertinib	Patients treated with Furmonertinib

Primary Outcome Measures

Name	Time	Method
Intracranial Disease Control Rate	Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.	The percentage of subjects who have a best CNS lesion response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator, will be assessed up to 2 years.
Intracranial progression-free survival	Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.	Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Intracranial Objective response rate	Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.	Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response, will be assessed up to 2 years.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.	Progression-free survival (PFS) is defined as the time from first dose of Furmonertinib recorded until the date of disease progression based on investigator assessment.
Overall Survival	The time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.	Overall survival is defined as the time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.
Safety/Adverse event	From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib	Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.

Trial Locations

Locations (1)

Tangdu Hopspital; 🇨🇳 Xi'an, Shanxi, China