Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue

• Clinical Benefit Response [ Time Frame: within and between each chemo-cycle (21 days) ] [ Designated as safety issue: No ]
  
• Incidence of Grade III plus IV Neutropenia [ Time Frame: within and between each chemo-cycle (21 days) ] [ Designated as safety issue: Yes ]
  

• Quality of Life Assessments [ Time Frame: within and between each chemo-cycle (21 days) ] [ Designated as safety issue: No ]
  
• The blood c-reactive protein level which is related to weight change [ Time Frame: within and between each chemo-cycle (21 days) ] [ Designated as safety issue: No ]
  
• Tumor Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  
• Survival Time [ Time Frame: one year ] [ Designated as safety issue: No ]
  
• Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption [ Time Frame: within and beween each chemo-cycle (21 days) ] [ Designated as safety issue: Yes ]
  

This is a multi-center, double-blind, randomized and placebo-controlled study to evaluate complementary effect of PG2 in patients with advanced non-small-cell lung cancer under conventional chemotherapy. Patients with Stage IIIb-IV non-small-cell lung cancer will be screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.

All enrolled patients will be randomized to PG2 or Placebo arm and will receive the cisplatin-based chemotherapy treatment (Cisplatin 75mg/m2 and Docetaxel 60mg/m2 on Day1) during the first three 21-day chemo-cycles. Chemo regimen modification is allowable, as usual, in case of disease progression or unacceptable toxicity (see Section 6). After randomization, each patient will be administered with PG2 or placebo for 4 days in the 1st week, 3 days in the 2nd week and 3 days in the 3rd week of each chemo-cycle for 3 cycles (Dosing Schedule in Section 6). Total 10 doses will be given in each cycle.