A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+) (AvaTa)

This is an interventional treatment trial for EGFR Positive Non-small Cell Lung Cancer Read More

Inclusion Criteria:

• Pathologically confirmed stage IIIB & IV non-small cell lung cancer other than squamous cell carcinoma
• Patients with one or more measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Locally diagnosed sensitive EGFR mutation positive (Exon 19 deletion or L858R)
• ECOG performance 0~1
• Age ≥ 19 years and - No previous treatment

Adequate organ function by following:

• ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL
• Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, If Liver metastasis, Serum bilirubin < 3 x UNL, AST (SGOT) and ALT (SGPT) < 5 x UNL
• Serum Cr ≤ 1 x UNL

• Patients who have had undergone radiotherapy are acceptable if patients meet all of the following criteria:

  • No history of irradiation to pulmonary tumor lesions.
  • In case of palliative irradiation to bone lesions in lung: at least 12 weeks must have passed at the date of registration since the last irradiation of the sites.
  • In case of irradiation to non-pulmonary sites: at least two weeks must have passed at the date of inclusion since the last irradiation of the sites

• At the time of registration, at least the following period has passed since last date of the prior therapy or procedure:

  • Surgery(including exploratory/ examination thoracotomy): 4 weeks
  • Pleural cavity drainage: 1 weeks
  • Pleurodesis without anti-neoplastic agents (inclusive of BRM such as Picibanil): 2 week
  • Biopsy accompanied by incision (including thoracoscopic biopsy): 2 week
  • Procedure for trauma (exclusive of patients with unhealed wound): 2 weeks
  • Transfusion of blood, preparation of hematopoietic factor: 2 week
  • Puncture and aspiration cytology: 1 week
  • Other investigational product: 4 weeks
• Written informed consent form

Exclusion Criteria:

• Previous history of malignancy within 3 years from study entry except treated non-melanomatous skin cancer, uterine cervical cancer in situ, or thyroid cancer
• Prior chemotherapy or systemic anti-cancer therapy for metastatic disease but postoperative adjuvant or neoadjuvant therapy of 6 months or more previously is allowed
• Patients who received previous treatment for lung cancer with drugs
• Symptomatic or uncontrolled central nervous system (CNS) metastases
• Patients with increased risk of bleeding, clinically significant cardiovascular diseases, a history of thrombosis or thromboembolism in the 6 months prior to treatment, gastrointestinal problems, and neurologic problems
• Any significant ophthalmologic abnormality
• Pre-existing parenchymal lung disease such as pulmonary fibrosis
• Known allergic history of Erlotinib or Bevacizumab
• Interstitial lung disease or fibrosis on chest radiogram
• Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
• Pregnant or nursing women