NCT07092202View on ClinicalTrials.gov

Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases

PHASE4RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 15, 2025

Primary Completion Date

May 1, 2027

Study Completion Date

November 1, 2027

Conditions
Leptomeningeal MetastasisNSCLCIntrathecal ChemotherapyTyrosine Kinase Inhibitor
Interventions
DRUG

Firmonertinib

Firmonertinib 160mg po qd

DRUG

Intrathecal injection of pemetrexed

Intrathecal injection of pemetrexed. Weight above 50kg: Induction period: 40mg/time, d1, d5 (q3w, x 4 cycles); Consolidation period: 40mg/time, q4w (pause when cerebrospinal fluid ctDNA is negative); Weight below 50kg: Induction period: 30mg/time, d1, d5 (q3w, x 4 cycles); Consolidation period: 30mg/time, q4w (pause when cerebrospinal fluid ctDNA is negative)

Trial Locations (1)

430022

RECRUITING

Wuhan Union Hospital, Wuhan

All Listed Sponsors
lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER