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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
Full 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
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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;
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46 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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