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Report for Clinical Trial NCT01933347

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT01933347 Non Small Cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Gefitinib

Description: Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression.
Type: Drug
Group Labels: 1

Gefitinib 250mg/d


Primary Outcomes

Measure: Disease Control Rate (DCR)

Time: week 8

Secondary Outcomes

Measure: objective response rate (ORR), progressive-free survival (PFS), overall survival(OS)

Time: until the death of last subject or 2 years after enrollment

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

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. --- L858R ---

Third-line Treatment of Gefitinib in NSCLC Patients 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 Disease Control Rate (DCR). --- L858R ---

Third-line Treatment of Gefitinib in NSCLC Patients 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 Disease Control Rate (DCR). --- L858R --- --- L858R ---

2. Male or female aged 18 years or older; 3. Subjects were diagnosed with stage IIIB or IV NSCLC before starting the first dose of gefitinib third-line treatment; 4. EGFR exon 19 deletion or exon 21 L858R substitution mutation confirmed; 5. ECOG performance status 0-2; 6. Life expectancy of at least 12 weeks or longer; 7. Has at least one measureable lesion by RECIST 1.1; 8. 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). --- L858R ---

Non Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung - 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 --- L858R ---

Non Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung - 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 --- L858R --- --- L858R ---



HPO Nodes


HPO: