Third-line Treatment of Gefitinib in NSCLC Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the disease control rate (DCR) of gefitinib as third-line retreatment in stage IIIB/IV NSCLC with EGFR 19del/L858R positive mutation patients who had benefited from first-line gefitinib treatment with EGFR 19del/L858R positive mutation and tumor progression after the second-line chemotherapy

Detailed Description
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Primary Study Objective: To evaluate the disease control rate (DCR) of gefitinib as third-line retreatment in stage IIIB/IV NSCLC with EGFR 19del/L858R positive mutation patients who had benefited from first-line gefitinib treatment with EGFR 19del/L858R positive mutation and tumor progression after the second-line chemotherapy Secondary Study Objectives: To evaluate objective response rate (ORR), progressive-free survival (PFS), overall survival(OS) and quality of life (QoL) of gefitinib as third-line retreatment in NSCLC patients To evaluate the safety of gefitinib as third-line treatment in NSCLC patients Exploratory analyses: To dynamically monitor EGFR mutation status and explore the relationship with clinical outcome

Official Title
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Third-line Treatment of Gefitinib in NSCLC Patients Who Had Received First-line Gefitinib With EGFR 19del/L858R Mutation and Tumor Progression After the Second-line Chemotherapy: a Single-arm, Prospective and Multi-center Study

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject or legal guardian could understand and sign informed consent form. Male or female aged 18 years or older; Subjects were diagnosed with stage IIIB or IV NSCLC before starting the first dose of gefitinib third-line treatment; EGFR exon 19 deletion or exon 21 L858R substitution mutation confirmed; ECOG performance status 0-2; Life expectancy of at least 12 weeks or longer; Has at least one measureable lesion by RECIST 1.1; NSCLC of enrolled subjects previously progressed after first-line gefitinib treatment (PFS ≥ 6 months) and progressed again after second-line chemotherapy (not limited for chemotherapy regimen, ≥ 4 cycles of chemotherapy). Investigator considers adopting third-line gefitinib retreatment; Criteria for laboratory examinations: Total bilirubin (TB) ≤ 1.5 times upper limit of normal Aspartate aminotransferase(AST), alanine aminotransferase (ALT) ≤2 times upper limit of normal; for subjects with hepatic metastasis, AST,ALT≤ 5 times upper limit of normal Creatinine clearance≥45ml/min Exclusion Criteria: Known severe hypersensitivity to gefitinib or any ingredients of the product; Patients with prior exposure to agents directed at the EGFR axis except gefitinib (e.g. erlotinib, cetuximab, trastuzumab) ; Pre-existing interstitial lung disease or pulmonary fibrosis evidenced by CT scan at baseline; Neutrophil count <1.0×109/L or platelet count <50×109/L; Severe infection, uncontrolled systemic disease (e.g cardiopulmonary insufficiency, fatal arrhythmias, hepatitis, etc); Pregnancy or breast-feeding; Women of childbearing age refuse to take adequate contraception measures during gefitinib treatment Subjects with other malignant tumors combined; Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication; Subjects are unable to take medications orally or have digestive malabsorption; Investigators consider subjects should not be involved in the study.

Ages Eligible for Study
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Minimum Age: 18 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: Gefitinib 250mg/d<br>Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression, perform scheduled visits in investigational sites at interview day and complete related examinations during follow-up period. | Drug: Gefitinib<br>* Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression.<br>* Other names: Iressa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) |  | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate (ORR), progressive-free survival (PFS), overall survival(OS) |  | until the death of last subject or 2 years after enrollment |