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

T

Tang-Du Hospital

Status

Enrolling

Conditions

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

Treatments

Drug: Furmonertinib

Study type

Observational

Funder types

Other

Identifiers

NCT06352502
202112-28

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

30 participants in 1 patient group

Furmonertinib group
Description:
Patients treated with Furmonertinib
Treatment:
Drug: Furmonertinib

Trial contacts and locations

1

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Central trial contact

Jie Min, PhD; Haichuan Su, PhD

Data sourced from clinicaltrials.gov

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