Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

EGFRNSCLCFurmonertinibCNS 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

FurmonertinibDrug

Patients treated with Furmonertinib mesilate tablets orally

Also known as: AST2818

Furmonertinib group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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;

Sponsors & Collaborators

Tang-Du Hospital
Otherlead

Study Sites (1)

Tangdu Hopspital

Xi’an, Shanxi, 710038, China

RECRUITING

Haichuan Su, PhDCONTACT18629190366 such@fmmu.edu.cn

Jie Min, PhDCONTACT13709202616 minjie1504@163.com

Haichuan Su, PhDPRINCIPAL INVESTIGATOR

Jie Min, PhDSUB INVESTIGATOR

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

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

Actual (reported)

Primary Completion

September 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

Furmonertinib group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

Furmonertinib group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations