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

NCT07314216 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

  • NSCLC (Non-small Cell Lung Carcinoma)
  • Stage III
  • EGFR Uncommon Mutations

Interventions

DRUG

Firmonertinib

Oral administration

RADIATION

Definitive Thoracic Radiotherapy

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

Sponsors & Collaborators

  • Hunan Cancer Hospital

    lead OTHER

Principal Investigators

  • Huai Liu, M.Med. · Hunan Cancer Hospital

  • Xingxiang Pu, M.D. · Hunan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07314216 on ClinicalTrials.gov