Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy

Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy

A phase II study is conducted to determine the efficacy and safety of a single agent Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. The usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.

Inclusion Criteria:

• 19 Years and older

• Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage IIIB or IV)

• ≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated

• prior platinum based chemotherapy

• ECOG PS ≤ 2

• Life expectancy > 3 months

• Adequate organ function:

  • hematology: ANC ≥ 1.5×109/L, Platelet ≥ 100×109/L, hemoglobin ≥ 9.0g/dL
  • hepatic: total bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.0×ULN, ALP ≤2.0×ULN
  • renal: serum creatinine ≤ 1.5×ULN

• Signed a written informed consent

Exclusion Criteria:

• Active infection
• Symptomatic brain lesion
• Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
• Severe concurrent diseases
• Prior anticancer therapy within 4 weeks before enroll
• Active pregnancy test