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

EGF-R Positive Non-Small Cell Lung Cancer Clinical Trial

Official title:

Efficacy and Safety of Furmonertinib for Epidermal Growth Factor Receptor (EGFR) Sensitive Mutation Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis: a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352502
• Other study ID #: 202112-28
• Status: Recruiting
• Start date: January 28, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Tang-Du Hospital
• Contact: Haichuan Su, PhD
• Phone: 18629190366
• Email: such[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• CNS Metastases
• EGF-R Positive Non-Small Cell Lung Cancer
• Lung Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Furmonertinib
Patients treated with Furmonertinib mesilate tablets orally

Locations

Country	Name	City	State
China	Tangdu Hopspital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Objective response rate	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.	Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
Primary	Intracranial Disease Control Rate	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.	Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
Primary	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.
Secondary	Progression-free survival	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.	Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Secondary	Overall Survival	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.	The time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.
Secondary	Safety/Adverse event	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.	From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib