Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

Summary: The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

Detailed description: Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations. This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

Eligibility: Inclusion Criteria:
  -  Written informed consent provided.
  -  Aged 18-75 years.
  -  Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
  -  EGFR activating mutation in exon 19 or 21.
  -  Had completed four cycles of platinum-based adjuvant chemotherapy.
  -  Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy.
  -  ECOG performance status of 0-1.
  -  Had a life expectancy of 12 weeks or more.
  -  Adequate hematological function, adequate liver function and renal function.
  -  Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  -  Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
  Exclusion Criteria:
  -  Had had previous chemotherapy besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
  -  Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
  -  Any evidence confirmed tumor recurrence before investigational therapy.
  -  Known severe hypersensitivity to icotinib or any of the excipients of this product.
  -  Evidence of clinically active interstitial lung disease.
  -  Eye inflammation not fully controlled or conditions predisposing the subject to this.
  -  Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  -  Known human immunodeficiency virus (HIV) infection.
  -  Pregnancy or breast-feeding women.
  -  Ingredients mixed with small cell lung cancer patients.
  -  History of neurologic or psychiatric disorders.

Relevance to patient case: not relevant