Primary Tumor Resection With EGFR TKI for Stage IV NSCLC (NCT05215548) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Primary Tumor Resection With EGFR TKI for Stage IV NSCLC
Taiwan100 participantsStarted 2021-09-27
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. (the biopsy surgery required for the diagnosis of lung cancer was not excluded)
* pregn…
What they're measuring
1
2 year progression free survival rate
Timeframe: start date of afatinib assessed up to 2 years