The study revealed that patients with a broad range of clinical characteristics including gender, ethnicity, smoking status, and tumor histology benefited from treatment with erlotinib see more in this setting. Patients had a PFS of 14.3 weeks, and while this study did not have a control arm, the PFS seen with erlotinib in the TRUST trial was almost twice that observed in the placebo arm of BR.21 (7.2 weeks). Patients in the TRUST study had an overall disease control rate of 70% at the time of analysis [37]. In the TITAN trial, 424 patients who progressed on an initial platinum-based chemotherapy were

randomly assigned to erlotinib or chemotherapy with either docetaxel or pemetrexed at the investigator’s discretion. There was no difference in OS (median 5.3 months with erlotinib vs 5.5 months with chemotherapy, HR 0.96) or PFS (median 6.3 weeks with erlotinib vs 8.6 weeks with chemotherapy) between both arms [38]. The SATURN (Sequential Tarceva in Unresectable Lung Cancer) phase 3 clinical trial is evaluated whether erlotinib is effective as maintenance therapy Protein Tyrosine Kinase inhibitor in advanced NSCLC. In this multicenter, double-blind, randomized study, 850 patients with advanced (stage IIIB/IV) NSCLC were randomized to receive either erlotinib (150 mg/day) or placebo,

after documented disease control (CR/PR/SD), after 4 cycles of standard platinum-based chemotherapy. Treatment is continued until disease progression, unacceptable toxicity, or death. The primary endpoint of SATURN is to determine whether administration

of maintenance erlotinib after standard platinum-based is beneficial. Thiamine-diphosphate kinase PFS was better with erlotinib versus placebo with HR 0.71, and overall survival HR was 0.81 [39]. The improvement in PFS was greater in patient with EGFR mutation (HR 0.009). FAST-ACT: A phase II randomized double-blind trial of sequential erlotinib and chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer (NSCLC), a placebo-control randomized phase 2 study of 150 unselected patients from Asia and Australia using gemcitabine and carboplatin on day 1 and day 8 subsequently followed by erlotinib from days 15 to 28. All patients received erlotinib or placebo as maintenance therapy. Tumor RR was 37% versus 24% in favor of the sequential erlotinib study arm. Median progression-free survival was 7.2 months with erlotinib versus 5.5 months with placebo [40]. Another international double- blind randomized trial (called ATLAS) found a benefit from combining 2 targeted maintenance therapies after initial treatment in patients with advanced non-small cell lung cancer. The trial revealed that combination therapy with erlotinib and bevacizumab is superior to bevacizumab alone for delaying disease progression. A total of 768 patients were randomized to receive bevacizumab plus erlotinib or bevacizumab plus placebo, after initial treatment with bevacizumab.