NCT05215548

Primary Tumor Resection With EGFR TKI for Stage IV NSCLC

A Phase II Study of Primary Tumor Resection for Stage IV Non-small-cell Lung Cancer Without Progression After First-line Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In Taiwan, non-small cell lung cancer (NSCLC) has been the leading cause of cancer death, making a phenomenal impact on public health. By understanding the oncogenic driver mutations of NSCLC (e.g. EGFR mutation or ALK rearrangement), the target therapy has taken the place of chemotherapy for its effectiveness and specificity, becoming the new standard of care for stage IV NSCLC. Despite the progress of medical treatment, the majority of patients with stage IV NSCLC still underwent disease progression after a period of time. Noticeably, more than half of the progression was restricted to the original sites of the tumor. It brings up the hypothesis that a combination of local consolidative therapy (e.g. surgery or radial therapy) and medical treatment could be beneficial for these patients. This has been advocated by the latest clinical trials as well. 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 the progression-free survival. This project is supposed to establish a new treatment protocol for stage IV NSCLC with EGFR mutation.

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-09-27
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2022-01-31
• Last updated: 2025-02-19

Locations

2 sites across 1 country: Taiwan