6/28/23, 11:44 PM OAK Pathway Feedback Search Clinical Topics Home Studies OAK OAK Disease Non-small cell lung cancer Trial question What is the effect of atezolizumab in patients with previously treated non-small cell lung cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 39.1% female N = 1225 60.9% male 1225 patients (330 female, 520 male) Inclusion criteria: patients with squamous or non-squamous non-small cell lung cancer who had received one to two previous cytotoxic chemotherapy regimens for stage IIIB or IV non-small cell lung cancer Key exclusion criteria: history of autoimmune disease, previous treatments with docetaxel, CD137 agonists, anti-CTLA4, or therapies targeting the PD-L1 and PD-1 pathway Interventions N=425 atezolizumab (intravenous 1200 mg fixed dose every 3 weeks) N=425 docetaxel (IV at 75 mg/m every 3 weeks) Primary outcome https://web.pathway.md/studies/recIQBTEFGYi7Qt6e 1/2 6/28/23, 11:44 PM OAK Pathway Overall survival in intention-to-treat population 13.8 months 13.8 10.4 months 9.6 6.9 months 3.5 months Significant increase 0.0 months Atezolizumab Docetaxel Significant increase in overall survival in the intention-to-treat population (13.8 months vs. 9.6 months; HR 1.37, 95% CI 1.15 to 1.61) Secondary outcomes No significant difference in progression-free survival in the intention-to-treat population (89% vs. 88%; HR 0.95, 95% CI 0.82 to 1.1) Safety outcomes Significant difference in treatment-related grade 3 or 4 adverse events (15% vs. 43%). Conclusion In patients with squamous or non-squamous non-small cell lung cancer who had received one to two previous cytotoxic chemotherapy regimens for stage IIIB or IV non-small cell lung cancer, atezolizumab was superior to docetaxel with respect to overall survival in the intention-to-treat population. Reference Rittmeyer A, Barlesi F, Waterkamp D et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. Open reference URL https://web.pathway.md/studies/recIQBTEFGYi7Qt6e 2/2