Status:
ACTIVE_NOT_RECRUITING
Primary Tumor Resection With EGFR TKI for Stage IV NSCLC
Lead Sponsor:
National Taiwan University Hospital
Conditions:
NSCLC Stage IV
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 ...
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. EG...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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.
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05215548
Start Date
September 27 2021
End Date
October 1 2027
Last Update
February 19 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan, 100
2
National Taiwan University Cancer Center
Taipei, Taiwan, 106