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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06352502
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tang-Du Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Haichuan Su, PhD
Principal Investigator Affiliation	Tang-Du Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	EGF-R Positive Non-Small Cell Lung Cancer, CNS Metastases

Additional Details

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.

Arms & Interventions

Arms

: Furmonertinib group

Patients treated with Furmonertinib

Interventions

Drug: - Furmonertinib

Patients treated with Furmonertinib mesilate tablets orally

Contact a Trial Team

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International Sites

Tangdu Hopspital, Xi'an, Shanxi, China

Status

Recruiting

Address

Tangdu Hopspital

Xi'an, Shanxi, 710038

Site Contact

Haichuan Su, PhD

such@fmmu.edu.cn

18629190366

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