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Third-line Treatment of Gefitinib in NSCLC Patients

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ClinicalTrials.gov Identifier: NCT01933347
Recruitment Status : Unknown
Verified February 2017 by Guangdong Association of Clinical Trials.
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2013
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials

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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Gefitinib Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 7, 2014
Actual Primary Completion Date : October 10, 2016
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Gefitinib 250mg/d
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
Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression.
Other Name: Iressa




Primary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: week 8 ]

Secondary Outcome Measures :
  1. objective response rate (ORR), progressive-free survival (PFS), overall survival(OS) [ Time Frame: until the death of last subject or 2 years after enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject or legal guardian could understand and sign informed consent form.
  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). Investigator considers adopting third-line gefitinib retreatment;
  9. 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:

  1. Known severe hypersensitivity to gefitinib or any ingredients of the product;
  2. Patients with prior exposure to agents directed at the EGFR axis except gefitinib (e.g. erlotinib, cetuximab, trastuzumab) ;
  3. Pre-existing interstitial lung disease or pulmonary fibrosis evidenced by CT scan at baseline;
  4. Neutrophil count <1.0×109/L or platelet count <50×109/L;
  5. Severe infection, uncontrolled systemic disease (e.g cardiopulmonary insufficiency, fatal arrhythmias, hepatitis, etc);
  6. Pregnancy or breast-feeding;
  7. Women of childbearing age refuse to take adequate contraception measures during gefitinib treatment
  8. Subjects with other malignant tumors combined;
  9. 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;
  10. Subjects are unable to take medications orally or have digestive malabsorption;
  11. Investigators consider subjects should not be involved in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933347


Locations
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China, Jiangsu
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Investigators
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Principal Investigator: Yong Song, Ph.D Nanjing PLA General Hospital

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Responsible Party: Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT01933347     History of Changes
Other Study ID Numbers: CTONG1304
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action