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NOT YET RECRUITING
NCT07314216
PHASE2

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

Sponsor: Hunan Cancer Hospital

View on ClinicalTrials.gov

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.

Official title: A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-01-01

Completion Date

2030-12-31

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

DRUG

Firmonertinib

Oral administration

RADIATION

Definitive Thoracic Radiotherapy

Conformal radiotherapy delivered to the primary tumor and involved regional lymph nodes.

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China