Primary Tumor Resection With EGFR TKI for Stage IV NSCLC

  • STATUS
    Recruiting
  • End date
    Jul 9, 2026
  • participants needed
    100
  • sponsor
    National Taiwan University Hospital
Updated on 9 April 2022

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.

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.

Details
Condition NSCLC Stage IV
Treatment Afatinib, therapeutic thoracic surgery
Clinical Study IdentifierNCT05215548
SponsorNational Taiwan University Hospital
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

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 or L858R 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 in accordance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP) guidelines and to the local legislation

Exclusion Criteria

Life expectancy <= 12 weeks
With underlying diseases such as moderate to severe Chronic Obstructive Pulmonary Disease or tuberculosis
With uncontrol diseases including acute infection, unstable angina or angina in recent 3 months, Heart failure(NYHA≥2), myocardial infarction in recent 6 months, severe arrhythmia, moderate to severe cirrhosis, moderate to severe chronic renal insufficiency, immune insufficiency, any systemic disease with poor prognosis after treatment
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
pregnant or breast-feeding woman
Previous treatment with other EGFR TKI. NOTE: Patients who are receiving initial afatinib (6-12 weeks) outside this study are not excluded
Disagree to receive Next Generation Sequencing for the lesion specimen after surgery
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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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