Abstract

Many clinical trials of molecular target drugs have been done against advanced lung cancer, however, majority did not meet the primary endpoint. Positive studies of EGFR-TKI such as BR21 and Interest used unselected populations of non-small cell lung cancer. It was quite difficult to explain why they were positive. In the present review, the difficulties of clinical trial design in molecular target drugs were discussed based on the differences of the magnitude of antitumor activity and the target tumor cell population between cytotoxic drugs and molecular target therapy. (J Lung Cancer 2008;7(1):1 �� 8)

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