Primary Tumor Resection With EGFR TKI for Stage IV NSCLC

Last updated: February 16, 2025
Sponsor: National Taiwan University Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

therapeutic thoracic surgery

Afatinib

Clinical Study ID

NCT05215548
202107141RINB
  • Ages > 20
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer

  • Stage IV non-small cell lung cancer which is amenable to thoracic surgery

  • Patients must have one of the following:NSCLC which harbors EGFR exon 19 deletion orL858R mutation.

  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1

  • Candidate for therapeutic intent surgery to at least one site of disease

  • Signed and dated written informed consent prior to admission to the study inaccordance with International Council for Harmonization of Technical Requirementsfor Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP) guidelines andto the local legislation

Exclusion

Exclusion Criteria:

  • Life expectancy <= 12 weeks

  • With underlying diseases such as moderate to severe Chronic Obstructive PulmonaryDisease or tuberculosis

  • With uncontrol diseases including acute infection, unstable angina or angina inrecent 3 months, Heart failure(NYHA≥2), myocardial infarction in recent 6 months,severe arrhythmia, moderate to severe cirrhosis, moderate to severe chronic renalinsufficiency, immune insufficiency, any systemic disease with poor prognosis aftertreatment.

  • With Cerebrovascular Accident complicated dependent activities of daily living.

  • Any other cancer with active treatment in recent 5 years.

  • receive thoracic surgery in the ipsilateral site with the lung cancer previously. （the biopsy surgery required for the diagnosis of lung cancer was not excluded)

  • pregnant or breast-feeding woman

  • Previous treatment with other EGFR TKI. NOTE: Patients who are receiving initialafatinib (6-12 weeks) outside this study are not excluded

  • Disagree to receive Next Generation Sequencing for the lesion specimen aftersurgery.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: therapeutic thoracic surgery
Phase: 2
Study Start date:
September 27, 2021
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • National Taiwan University Cancer Center

    Taipei, 106
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

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