[Phase II study of lung cancer--evaluation of new drug in small cell lung cancer (SCLC) and phase II testing of analogues].

The purpose of this report is to review the problems in the evaluation of new drugs in SCLC and phase II testing of analogues in lung cancer. SCLC is one of the most chemotherapy-sensitive solid tumours and patients (pts) who relapse after their first-line treatment are likely to have resistant tumors, precluding the appropriate evaluation of new drugs, especially analogues. However, it is ethically difficult to evaluate new drugs in untreated pts with SCLC. Based on many issues, We recommended that new drugs should be evaluated in "good" pts with extensive-stage SCLC and that the trial design should include early stopping rules as well as a crossover to an active alternative regimen such as etoposide and cisplatin for non-responders. Also, I recommended that the endpoint for a positive phase II study with an analogue depends upon which of the following four ways the analogue's superiority is hope for; (1) superior efficacy in responsive tumors; (2) broader spectrum; (3) cross-over resistance to the parent structure; (4) diminished toxicity.