An International Randomized Phase III Study of First-line Erlotinib Followed by Second-line Cisplatin + Gemcitabine Versus First-line Cisplatin + Gemcitabine Followed by Second-line Erlotinib in Advanced Non Small Cell Lung Cancer
Chemotherapy for patients affected by advanced NSCLC has demonstrated only modest
improvement in survival rates over best supportive care: the prognosis of patients remains
poor and the side effects are considerable. Therefore, novel agents are urgently needed for
this disease. One way to improve effectiveness of therapies is to use non-chemotherapeutic
agents that act on biological targets and cause fewer systemic side effects.
Erlotinib(Tarceva)is a biological therapy that in recent clinical trials has shown promise
in first- and second-line treatment of advanced NSCLC.
In this trial, patients will be randomized to one of two treatment strategies:
- erlotinib taken by mouth daily; and, if disease progression occurs, to be followed by
chemotherapy with cisplatin and gemcitabine at standard doses for 6 cycles
- chemotherapy with cisplatin and gemcitabine given intravenously at standard doses for 6
cycles; and if disease progression occurs to be followed by erlotinib taken by mouth daily
The study is conducted with the partial support of Roche, S.p.A.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cesare Gridelli, M.D.
S.G. Moscati Hospital, Avellino, Italy
Italy: Ethics Committee