NCT01933347CompletedPhase 2
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
Guangdong Association of Clinical Trials1 site in 1 country46 target enrollmentStarted: April 7, 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Disease Control Rate (DCR)
Study Overview
Brief Summary
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
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Gefitinib 250mg/d
Experimental
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.
Intervention: Gefitinib (Drug)
Outcomes
Primary Outcomes
Disease Control Rate (DCR)
Time Frame: week 8
Secondary Outcomes
- objective response rate (ORR), progressive-free survival (PFS), overall survival(OS)(until the death of last subject or 2 years after enrollment)
Investigators
Study Sites (1)
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