High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital

About this trial

EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.

Eligibility criteria

Qualifiers

Signed written informed consent before any study-related procedure.

Age ≥ 18 years.

ECOG PS of 0 to 1 at screening,and with no clinically significant deterioration in the previous 2 weeks.

Expected survival ≥12 weeks.

Disqualifiers

Small cell lung carcinoma;

History of hypersensitivity to active or inactive excipients of investigational agent with a similar chemical structure.

Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis.

Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI).

Trial design

Treatments tested in this trial

  • Furmonertinib

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators