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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Clinical Benefit Response
within and between each chemo-cycle (21 days)
Reury-Perng Perng, M.D., Ph.D.
Taipei Veterans General Hospital, Tawian
Taiwan: Institutional Review Board