Gefitinib in Non Small Cell Lung Cancer

Table 5

Ongoing phase III/IV studies in NSCLC.

Study phase	Line of treatment	ClinicalTrials.gov ID	Setting	Estimated sample size (pts)	Treatment	Primary endpoint
III	1st	NCT00770588	Maintenance after first line platinum-based chemotherapy	296	Gefitinib 250 mg versus Placebo	Progression-free survival
III	1st	NCT00144066	Maintenance after first line platinum-based chemotherapy	600	Gefitinib 250 mg versus Placebo	Overall survival
IV	1st	NCT01203917	Selected Caucasian pts	100	Gefitinib 250 mg	Objective response rate
III	≥2nd	NCT01066195	Never smoker pts with adenocarcinoma	129	Gefitinib 250 mg versus Pemetrexed	Progression-free survival
III	1st	NCT01017874	Selected East Asian pts	226	Gefitinib alone versus Cisplatin-Pemetrexed→Gefitinib	Progression-free survival
IV	1st	NCT00173524	First line Asian pts	200	Gefitinib versus Platinum-based chemotherapy	Cost-effectiveness
					Systemic and radiant
III	1st-2nd	NCT00955695	Never smoker adenocarcinoma pts treated with prophylactic cranial irradiation	242	Prophylactic whole brain radiation therapy during gefitinib 250 mg or erlotinib 150 mg	Incidence of symptomatic brain metastases