bUnadjusted for multiple comparisons. cHRs adjusted for ECOG PS, gender, disease stage, and basis for pathological diagnosis (histopathological/cytopathological). dIncludes adenocarcinoma, large cell, and other histologies except those with squamous cell type. eThe subgroup of “other” represents patients with a primary diagnosis of NSCLC whose disease did not clearly qualify as adenocarcinoma, squamous cell carcinoma, or large cell carcinoma. Figure 2: Kaplan-Meier Curves for Overall Survival ALIMTA plus Cisplatin (AC) versus Gemcitabine plus Cisplatin (GC) in NSCLC - Nonsquamous NSCLC and Squamous Cell NSCLC. 14.2 Non-Small Cell Lung Cancer - Maintenance A multi-center, randomized, double-blind, p lacebo-controlled study was conducted in 663 patients with Stage IIIb/IV NSCLC who did not progress after four cycles of platinum-based chemotherapy. Patients who did not progress were randomized 2:1 to rec eive ALIMTA or placebo immediately following platinum-based chemotherapy. ALIMTA was administered intravenously over 10 minutes at a dose of 500 mg/m2on Day 1 of each 21-day cycle, until disease progression. Patients in both study arms received folic acid, vitamin B 12, and dexamethasone [see Dosage and Administration (2.3)] . The study was designed to demonstrate superior progression-free survival and overall survival of ALIMTA over placebo. Progression-free survival (PFS) was assessed by independent review. Patient characteristics of the intent to treat (ITT) populati on are shown in Table 12.