Table 5: Ongoing phase III/IV studies in NSCLC.

Study phaseLine of IDSettingEstimated sample size (pts)TreatmentPrimary endpoint

III1stNCT00770588Maintenance after first line platinum-based chemotherapy296Gefitinib 250 mg versus PlaceboProgression-free survival
III1stNCT00144066Maintenance after first line platinum-based chemotherapy600Gefitinib 250 mg versus PlaceboOverall survival
IV1stNCT01203917Selected Caucasian pts100Gefitinib 250 mgObjective response rate
III≥2ndNCT01066195Never smoker pts with adenocarcinoma129Gefitinib 250 mg versus PemetrexedProgression-free survival
III1stNCT01017874Selected East Asian pts226Gefitinib alone versus Cisplatin-Pemetrexed GefitinibProgression-free survival
IV1stNCT00173524First line Asian pts200Gefitinib versus Platinum-based chemotherapyCost-effectiveness

Systemic and radiant
III1st-2ndNCT00955695Never smoker adenocarcinoma pts treated with prophylactic cranial irradiation242Prophylactic whole brain radiation therapy during gefitinib 250 mg or erlotinib 150 mgIncidence of symptomatic brain metastases