Third-line Treatment of Gefitinib in NSCLC Patients

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933347
• Other study ID #: CTONG1304
• Status: Completed
• Phase: Phase 2
• Start date: April 7, 2014
• Est. completion date: April 10, 2018

Study information

• Verified date: April 2018
• Source: Guangdong Association of Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Nanjing General Hospital of Nanjing Military Command	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate (DCR)		week 8
Secondary	objective response rate (ORR), progressive-free survival (PFS), overall survival(OS)		until the death of last subject or 2 years after enrollment