NCT05215548RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Jan 2022
- Start date
- 27 Sept 2021
- Primary completion date
- Oct 2026
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05215548
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 27 Sept 2021 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Disagree to receive Next Generation Sequencing for the lesion specimen after surgery.
Other illness
- 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.
- Any other cancer with active treatment in recent 5 years.
Lab values
- Previous treatment with other EGFR TKI. NOTE: Patients who are receiving initial afatinib (6-12 weeks) outside this study are not excluded
Other
- Life expectancy \<= 12 weeks
- With Cerebrovascular Accident complicated dependent activities of daily living.
- pregnant or breast-feeding woman
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Cancer Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.