Clinical trial NCT05215548: Primary Tumor Resection With EGFR TKI for Stage IV NSCLC
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: NSCLC Stage IV
Keywords: epidermal growth factor receptor tyrosine inhibitor
lung adenocarcinoma
surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 to establish a new treatment protocol for stage IV NSCLC with EGFR mutation.

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. EGFR mutation or ALK rearrangement), the target therapy has taken the place of chemotherapy for its effectiveness and specificity, becoming the new standard of care for stage IV NSCLC. Despite the progress of medical treatment, the majority of patients with stage IV NSCLC still underwent disease progression after a period of time. Noticeably, more than half of the progression was restricted to the original sites of the tumor. It brings up the hypothesis that a combination of local consolidative therapy (e.g. surgery or radial therapy) and medical treatment could be beneficial for these patients. This has been advocated by the latest clinical trials as well.

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 the progression-free survival. This project is supposed to establish a new treatment protocol for stage IV NSCLC with EGFR mutation.

Eligibility criteria: 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.

Primary outcomes:
measure: 2 year progression free survival rate
timeFrame: start date of afatinib assessed up to 2 years
Secondary outcomes:
measure: Progression free survival
timeFrame: From the start date of afatinib assessed up to 4 years
measure: Overall survival
timeFrame: From the start date of afatinib assessed up to 4 years
measure: Treatment-related adverse events
timeFrame: From the start date of afatinib assessed up to 4 years
measure: R0 resection rate
timeFrame: From the start date of afatinib assessed up to 12 weeks
measure: resistant mutation events
timeFrame: 12 weeks to 4 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
Study officials:
References: