RecruitingPhase 2NCT07314216

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

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


Sponsor

Hunan Cancer Hospital

Enrollment

15 participants

Start Date

Jun 22, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Definitive Thoracic Radiotherapy and a drug called Firmonertinib for people with egfr uncommon mutations, nsclc (non-small cell lung carcinoma), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFirmonertinib

Oral administration

RADIATIONDefinitive Thoracic Radiotherapy

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


Locations(1)

Hunan Cancer Hospital

Changsha, Hunan, China

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NCT07314216


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