Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Third-line Treatment of Gefitinib in NSCLC Patients

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

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

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.

Relevance to patient case: definitely relevant