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Primary Tumor Resection With EGFR TKI for Stage IV NSCLC

NCT05215548 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-19

No results posted yet for this study

Summary

Our project is going to enroll patients with stage IV NSCLC with EGFR mutation and evaluate whether primary tumor resection after receiving the afatinib can prolong survival. This project is supposed to establish a new treatment protocol for stage IV NSCLC with EGFR mutation.

Conditions

  • NSCLC Stage IV

Interventions

PROCEDURE

therapeutic thoracic surgery

The surgery group would receive therapeutic thoracic surgery with maximal local regional control intent and would prescribe with maintenance afatinib therapy after operation. Patients continue afatinib 1 to 2 weeks after surgery.

DRUG

Afatinib

The patient take afatinib treatment for 12 weeks treatment and then receive systemic image study examination before randomization. If exam result showed progression the patient would be excluded from the study. Treatment response was evaluated according to the Response Evaluation Criteria in Solid Tumors (version 1.1).

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • Taiwan

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 NCT05215548 on ClinicalTrials.gov