Clinical trial NCT06352502: An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: EGF-R Positive Non-Small Cell Lung Cancer
CNS Metastases
Keywords: EGFR
NSCLC
Furmonertinib
CNS metastases
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Intracranial Objective response rate
timeFrame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
measure: Intracranial Disease Control Rate
timeFrame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
measure: Intracranial progression-free survival
timeFrame: Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Secondary outcomes:
measure: Progression-free survival
timeFrame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
measure: Overall Survival
timeFrame: The time from beginning of furmonertinib treatment until death due to any cause and will be assessed up to 3 years.
measure: Safety/Adverse event
timeFrame: From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hopspital
state: Shanxi
Study officials:
affiliation: Tang-Du Hospital
name: Haichuan Su, PhD
role: PRINCIPAL_INVESTIGATOR
References: