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NOT YET RECRUITING
NCT07298148
PHASE2

Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.

Official title: A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-01-01

Completion Date

2032-12-31

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

Firmonertinib 160mg

Patients enter an 8-week induction phase at 80 mg once daily. Those with stable disease per RECIST v1.1 at Week 8 escalate to 160 mg daily until disease progression or unacceptable toxicity.