Third-line Treatment of Gefitinib in NSCLC Patients

• Status: Completed
• Trial end date: 2018-04-10
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Association of Clinical Trials
• Treatments: Gefitinib

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.