Tests lung tumor surgery after afatinib in EGFR-mutant advanced lung cancer
Tests removing the main tumor after afatinib in EGFR-mutant lung cancer.
Key facts
- Who runs it
- National Taiwan University Hospital
- Where
- Taipei, TaiwanSee the 2 sites
- Trial code
- Registry title
- Primary Tumor Resection With EGFR TKI for Stage IV NSCLC
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 100 people, planned
- Started
- 27 Sept 2021
- Expected to end
- Oct 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- therapeutic thoracic surgery
- Afatinib
- Record updated
- 22 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage IV non-small cell lung cancer who have an EGFR mutation and can have chest surgery. Surgery to remove the main tumour is tested after treatment with afatinib.
- Age
- 20 years or older
- Sex
- All sexes can join.
- Disease stage
- Stage IV non-small cell lung cancer that can be treated with chest surgery. Cancer confirmed by tissue or cell tests.
- Earlier treatment
- No earlier treatment with other EGFR TKI drugs. People already taking afatinib for 6-12 weeks outside this study can still join. No earlier chest surgery on the same side as the lung cancer, except a biopsy for diagnosis.
- Biomarker or test result
- The cancer must have an EGFR exon 19 deletion or an L858R mutation.
Main reasons for not taking part
- Life expectancy of 12 weeks or less
- Moderate to severe COPD or tuberculosis
- Uncontrolled serious illness such as heart failure, recent heart attack, severe cirrhosis or kidney problems
- Another cancer treated in the last 5 years
- Pregnant or breast-feeding women
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Previous treatment with other EGFR TKI. NOTE: Patients who are receiving initial afatinib (6-12 weeks) outside this study are not excluded
- Life expectancy <= 12 weeks
- With Cerebrovascular Accident complicated dependent activities of daily living
- pregnant or breast-feeding woman
Where in Taiwan
- National Taiwan University Cancer CenterTaipei, TaiwanContact: Jin-Shing Chen, M.D., Ph.DTaking people
- National Taiwan University HospitalTaipei, TaiwanContact: Pei-Hsing Chen, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group I : Surgery groupTreatment being tested
The surgery group would receive take 12 weeks of EGFR TKI before randomization. After randomization, the surgery group would receive thoracic surgery with maximal regional control intent. Patients continue afatinib 1 to 2 weeks after surgery until disease progression or unacceptable toxicity. The residual local and metastatic sites of disease could undergo either surveillance or maintenance radio-treatment at the discretion of the treating physician.
Treatment: therapeutic thoracic surgery and Afatinib
- Group II : Maintenance groupExisting treatment, for comparison
The control group would receive take 12 weeks of EGFR TKI before randomization. After randomization, the control group would receive afatinib until disease progression or unacceptable toxicity. The residual local and metastatic sites of disease could undergo either surveillance or maintenance radio-treatment at the discretion of the treating physician.
Treatment: Afatinib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests lung tumor surgery after afatinib in EGFR-mutant advanced lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 September 2026