High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs

Study Overview
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Brief Summary
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the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）

Detailed Description
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To evaluate the efficacy and safety by treating the advanced non small cell lung cancer (NSCLC) patients who have failure of standard dose EGFR-TKIs(Erlotinib or Gefitinib ) with high-dose, pulsatile Erlotinib(450mg every 3 days) or Gefitinib (1000mg every 4 days)

Official Title
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An Open,Multi Center Trial to Evaluate the Efficacy and Safety of High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced Non-Small Cell Lung Cancer Patients After Failure of Standard Dose EGFR-TKIs

Conditions
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Self Efficacy, Drug Toxicity

Intervention / Treatment
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* Drug: Erlotinib or Gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. NSCLC patients were confirmed by histology or cytology 2. Patients were ever treated with standard dose EGFR-TKIs(Erlotinib or Gefitinib )on which he/she achieved complete remission/partial remission,or maintained stable disease for 4 months.Disease progression at present (accord to RECISTv1.1 criteria） 3.At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; 4.Have an ECOG PS of 0-2 5.At least 8 weeks of expected survival time 6.Have no serious cardiovascular,hepatobiliary or renal disorders 7.Provision of a voluntarily given, personally signed and dated, written informed consent document 8.Must be in accordance with the following laboratory biochemical data: Hgb≥80g/L，WBC≥3.0×10^9/L，ANC≥1.0×10^9/L， PLT≥80×10^9/L Renal function：SCr≤ULN Liver function： if no hepatic metastases:AST/ALT≤2.5ULN if hepatic metastases:AST/ALT≤5ULN Exclusion Criteria: If the subject meet any of the following exclusion criteria ,he/she is no eligible to participate in this study Have chronic toxicity reaction(above grade 2) and not recovered( hair loss not include) Have Appeared skin rashes or diarrhea(above grade 3),or have any reason lead to decrement during standard dose EGFR-TKIs treatment Female subjects who are in pregnancy or lactation，or of childbearing age but don't take any contraceptive measures Current enrollment in another therapeutic clinical study Have any symptoms of brain metastases or leptomeningeal metastases Subjects will not be eligible if they have history of prior malignancy in past 5 years Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this study or known drug abuse/alcohol abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib or Gefitinib<br>Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months | Drug: Erlotinib or Gefitinib<br>* Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months<br>* Other names: high-dose, pulsatile Erlotinib or Gefitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy and safety | To evaluate the efficacy and safety by treating the advanced NSCLC patients who have failure of standard dose EGFR-TKIs with high-dose, pulsatile Erlotinib(600mg every 4 days) or Gefitinib (1000mg every 4 days) Radiologically measurable disease by RECIST v1.1 criteria: At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of a positron emission tomography (PET)/CT,ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced non-small cell lung cancer, High-dose, Pulsatile, EGFR-TKIs