6/28/23, 12:28 AM Crizotinib in advanced ALK-positive lung cancer Pathway Feedback Search Clinical Topics Home Studies Crizotinib in advanced ALK-positive lung cancer Crizotinib in advanced ALK-positive lung cancer Disease Non-small cell lung cancer Trial question What is the role of crizotinib in patients with previously treated advanced non-small cell lung cancer with ALK gene rearrangement? Study design Multi-center Open label RCT Population Characteristics of study participants 56.0% female N = 347 44.0% male 347 patients (194 female, 153 male) Inclusion criteria: patients with locally advanced or metastatic ALK-positive lung cancer who had received one prior platinum-based regimen Key exclusion criteria: age < 18 years, stable disease after one prior chemotherapy regimen, or still in the first-line treatment setting Interventions N=173 crizotinib (oral dose of 250 mg BID) N=174 chemotherapy (intravenous pemetrexed 500 mg/m of BSA or docetaxel 75 mg/m every 3 weeks) Primary outcome Median progression-free survival 7.7 months 7.7 https://web.pathway.md/studies/recfN4qybhtJ9b8sr 1/2 6/28/23, 12:28 AM Crizotinib in advanced ALK-positive lung cancer Pathway 5.8 months 3.9 months 3 1.9 months Significant increase 0.0 months Crizotinib Chemotherapy Significant increase in median progression-free survival (7.7 months vs. 3 months; HR 2.04, 95% CI 1.56 to 2.7) Secondary outcomes Significant increase in response (65% vs. 20%; RR 3.25, 95% CI 1.32 to 5.18) No significant difference in overall survival in an interim analysis (20.3 vs. 22.8; HR 0.98, 95% CI 0.65 to 1.47) Safety outcomes Significant differences in vision disorders (60% vs. 9%), diarrhea (60% vs. 19%), elevated aminotransferase (38% vs. 15%), dizziness (22% vs. 8%), dyspnea (13% vs. 19%), and alopecia (8% vs. 20%). Conclusion In patients with locally advanced or metastatic ALK-positive lung cancer who had received one prior platinum-based regimen, crizotinib was superior to chemotherapy with respect to median progression-free survival. Reference Shaw AT, Kim DW, Nakagawa K et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. Open reference URL https://web.pathway.md/studies/recfN4qybhtJ9b8sr 2/2