Primary tumor removal after EGFR inhibitor in stage IV NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 2 study, patients with EGFR-mutant stage IV NSCLC will receive afatinib, followed by surgical removal of the primary tumor when feasible, to see if the approach improves progression-free survival. The study aims to establish a new treatment protocol combining targeted therapy with local tumor control. Eligible participants should have good performance status and disease that can be surgically addressed. The trial is conducted at National Taiwan University Hospital and related centers in Taipei. Primary endpoints include progression-free survival and safety of the combined approach.

Why it matters

Who can join: the full rules

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)
* 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.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting
• National Taiwan University Cancer Center
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Jin-Shing Chen, M.D., Ph.D.
• Email: chenjs@ntu.edu.tw
• Phone: 886-2-2322-0322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.