drugset / Trial / NCT07314216

Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcinoma

NCT07314216

Phase 2 Recruiting 15 enrolled Hunan Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-arm, Phase II clinical study aimed at evaluating the efficacy and safety of 160mg fimonertinib in combination with definitive radiotherapy for patients with EGFR uncommon driver mutation-positive, Stage III unresectable lung adenocarcinoma. The primary endpoint is Progression-Free Survival (PFS), assessed by the investigator according to RECIST 1.1 criteria, defined as the time from the first dose to objective disease progression or death (from any cause). Secondary endpoints include PFS by different mutation types, OS, ORR, DCR, as well as adverse events and their severity.

Timeline

Start
2026-06-22
Primary completion
2030-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Firmonertinib Small molecule 160 mg Oral