Third-line Treatment of Gefitinib in NSCLC Patients

• Sponsor: Guangdong Association of Clinical Trials (Other)
• Overall Status: Completed
• CT.gov ID: NCT01933347
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arm: 1
• Actual Duration (Months): 48.1
• Patients Per Site Per Month: 1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• 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: Apr 7, 2014
• Actual Primary Completion Date: Apr 10, 2017
• Actual Study Completion Date: Apr 10, 2018

Arms and Interventions

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 Names: Iressa

Outcome Measures

Primary Outcome Measures

1. Disease Control Rate (DCR) [week 8]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing General Hospital of Nanjing Military Command	Nanjing	Jiangsu	China	210002

Sponsors and Collaborators

• Guangdong Association of Clinical Trials

Investigators

• Principal Investigator: Yong Song, Ph.D, Nanjing PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangdong Association of Clinical Trials
• ClinicalTrials.gov Identifier: NCT01933347
• Other Study ID Numbers: CTONG1304
• First Posted: Sep 2, 2013
• Last Update Posted: Feb 6, 2020
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Gefitinib

Study Results

No Results Posted as of Feb 6, 2020