Primary Tumor Resection With EGFR TKI for Stage IV NSCLC
ConditionNSCLC Stage IV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
therapeutic thoracic surgery
Procedure/SurgeryThe surgery group would receive therapeutic thoracic surgery with maximal local regional control intent and would prescribe with maintenance afatinib therapy after operation. Patients continue afatinib 1 to 2 weeks after surgery.
Afatinib
DrugThe patient take afatinib treatment for 12 weeks treatment and then receive systemic image study examination before randomization. If exam result showed progression the patient would be excluded from the study. Treatment response was evaluated according to the Response Evaluation Criteria in Solid Tumors (version 1.1).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group I : Surgery groupExperimental treatment 2 interventions
Group B: Group II : Maintenance groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
2 year progression free survival rate
Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.
Time frame
start date of afatinib assessed up to 2 yearsSecondary outcomes
1
Progression free survival
Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.
Time frame
From the start date of afatinib assessed up to 4 years2
Overall survival
Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.
Time frame
From the start date of afatinib assessed up to 4 years3
Treatment-related adverse events
It refers to the number of adverse events related to afatinib monotherapy or platinum-based chemotherapy as evaluated according to CTCAE v4.0.
Time frame
From the start date of afatinib assessed up to 4 years4
R0 resection rate
It is defined as the proportion of patients with negative surgical margin and no residual found under microscope after resection in all patients who have completed the thoracic surgery treatment.
Time frame
From the start date of afatinib assessed up to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov