Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma

Sponsor
Tongji University
Study ID
NCT05165355
Phase
PHASE2
Status
Unknown

Conditions

  • EGF-R Positive Non-Small Cell Lung Cancer
  • NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Furmonertinib — DRUG
    Furmonertinib (80 mg orally, once daily) for 3 years.

Study Details

This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection. The primary endpoint: 2-year DFS rate; The second endpoint: DFS

Key Dates

Start date
Dec 28, 2021
Status verified
Jan 2022
Primary completion
Nov 30, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Furmonertinib (80 mg orally, once daily) for 3 years.

Primary Outcome Measure

Disease Free Survival (DFS) rate at 2 years [ Time Frame: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years. ]

Central Contacts

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