Mitomycin, ifosfamide, and cisplatin have demonstrated the best single
-agent activity thus far in patients with non-small cell lung cancer (
NSCLC), the most common malignant disease in the western world. For th
is reason, we initiated a phase II study, giving these three agents in
combination (designated MIC) to 74 patients with inoperable NSCLC. Si
xty-six patients were evaluable for response, of whom 30 (45%) demonst
rated a partial response and 7 (11%) a complete response. These result
s, along with those obtained in two other phase II trials of MIC in NS
CLC, prompted us to begin a large-scale, multicenter, phase III study
of MIC in patients with inoperable limited-stage NSCLC. In this ongoin
g study, patients have been randomized to receive treatment with MIC a
nd radiotherapy or radiotherapy alone. We hope to resolve the issue of
whether a survival advantage is conferred on NSCLC patients treated w
ith radiotherapy in combination with this promising chemotherapeutic r
egimen.