Third-line Treatment of Gefitinib in NSCLC Patients

NCT01933347 | Completed Phase 2 DMC

• 1 other identifier: CTONG1304
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  week 8

Secondary Outcomes (1)

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

  until the death of last subject or 2 years after enrollment

Study Arms (1)

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.

Drug: Gefitinib

Interventions

Gefitinib DRUG

Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression.

Also known as: Iressa

Gefitinib 250mg/d

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (1)

Nanjing General Hospital of Nanjing Military Command

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yong Song, Ph.D

  Nanjing PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: April 7, 2014
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2018
• Last Updated: February 6, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)