Post-marketing Clinical Study (Phase III) Against Advanced Non-Small Cell Lung Cancer to be Initiated
First of its kind - A Large-Scale Comparative Study - in Japan

  This is a clinical study based on the global standard to be held at 43 institutions all over Japan. The study is also significant from the standpoint of global academic viewpoint; which aims to compare a concomitant therapy of paclitaxel and carboplatin, a concomitant therapy of gemcitabine hydrochloride and cisplatin and a concomitant therapy of vinorelbine and cisplatin, respectively, which are all admitted as standard treatment with a concomitant therapy of irinotecan and cisplatin as a control arm. (See attachment)

  The study is to evaluate efficacy and safety in terms of survival effect as primary endpoint. This is a large-scale and long-term comparison study as the number of cases for registration is 150 for each arm, the total number of cases for the four arms being 600; and as the enrollment period is three years and the follow-up period two years.

  The study is made feasible because the 3 anti-neoplastic drugs indicated for NSCLC were locally approved almost in the same period and, their post-marketing clinical studies will therefore be conducted in the same period, too. Using the 3 drugs which have demonstrated favorable response rates in their respective Phase II studies, we believe that the concerned study will contribute to more effective, newer therapeutic proposal against NSCLC in Japan.

  This clinical study is to be performed under the supervision of Dr. Masahiro Fukuoka, Professor at Kinki University School of Medicine, Dept.of Internal Medicine .

[Appendix]

Protocol
Multi-center cooperative study by randomized controlled trials using the central enrollment system

Group Composition
<Control therapy group>
  IP therapy group:
    (Irinotecan hydrochloride + Cisplatin)
<Investigational therapy groups>
  TC therapy group:
    (Paclitaxel+Carboplatin)
  GP Therapy Group:
    (Gemcitabine hydrochloride + Cisplatin)
  NP Therapy Group:
    (Vinorelbine ditartrate + Cisplatin)

Evaluation
[Efficacy]
  1) Primary Endpoint
          survival rate survival duration
  2) Secondary Endpoint
    (1)Antitumor Effect
        (response rate, response duration: evaluated according to RECIST
    (2)Time to Progressive Disease
    (3)Time to Treatment Failure
    (4)QOL (FACT-LQOL-ACD)

[Safety]
Adverse events (incidence, severity)