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

NCT06352502 | Recruiting

• 1 other identifier: 202112-28
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

EGF-R Positive Non-Small Cell Lung Cancer; CNS Metastases

Keywords

EGFR; NSCLC; Furmonertinib; CNS metastases

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (3)

• Progression-free survival

  Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.

• Overall Survival

  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

Study Arms (1)

Furmonertinib group

Patients treated with Furmonertinib

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Patients treated with Furmonertinib mesilate tablets orally

Also known as: AST2818

Furmonertinib group

Eligibility Criteria

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

Study Population

Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically and imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation.

You may qualify if:

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

You may not qualify if:

• Any Third-Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) before Furmonertinib initiation;
• Known hypersensitivity to Furmonertinib or its excipient components;
• Simultaneous systemic chemotherapy or WBI;
• 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;
• Any evidence of severe or uncontrolled systemic diseases;
• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hopspital

Xi’an, Shanxi, 710038, China

RECRUITING

MeSH Terms

Interventions

aflutinib

Study Officials

• Haichuan Su, PhD

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haichuan Su, PhD

CONTACT

18629190366; such@fmmu.edu.cn

Jie Min, PhD

CONTACT

13709202616; minjie1504@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 8, 2024
• Study Start: January 28, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)