6/28/23, 12:05 AM ALEX Pathway Feedback Search Clinical Topics Home Studies ALEX ALEX Disease Non-small cell lung cancer Trial question Is alectinib superior to crizotinib in patients with untreated ALK-positive non-small cell lung cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 56.0% female N = 303 44.0% male 303 patients (171 female, 132 male) Inclusion criteria: patients with previously untreated, advanced ALK-positive non-small cell lung cancer Key exclusion criteria: previous malignancy within the past 3 years; any gastrointestinal disorder or liver disease; history of organ transplant; pregnancy Interventions N=152 alectinib (at a dose of 600 mg BID) N=151 crizotinib (at a dose of 250 mg BID) Primary outcome Progression-free survival https://web.pathway.md/studies/reckQUzvnASXVtT32 1/2 6/28/23, 12:05 AM ALEX Pathway 68.4 % 68.4 51.3 % 48.7 34.2 % Significant increase 17.1 % NNT = 5 0.0 % Alectinib Crizotinib Significant increase in progression-free survival (68.4% vs. 48.7%; AD 19.7%, 95% CI 8.01 to 31.39) Secondary outcomes Significant decrease in CNS progression (12% vs. 45%; HR 0.16, 95% CI 0.1 to 0.28) No significant difference in response rate (82.9% vs. 75.5%; AD 7.4%, 95% CI -1.16 to 15.96) Safety outcomes No significant difference in adverse and serious adverse events. Conclusion In patients with previously untreated, advanced ALK-positive non-small cell lung cancer, alectinib was superior to crizotinib with respect to a progression-free survival. Reference Solange Peters, D Ross Camidge, Alice T Shaw et al. Alectinib versus Crizotinib in Untreated ALK- Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. Open reference URL https://web.pathway.md/studies/reckQUzvnASXVtT32 2/2