6/28/23, 12:28 AM CodeBreak 200 Pathway Feedback Search Clinical Topics Home Studies CodeBreak 200 CodeBreak 200 Disease Non-small cell lung cancer Trial question Is sotorasib superior to docetaxel in previously treated patients with advanced non-small cell lung cancer with KRASG12C mutation? Study design Multi-center Open label RCT Population Characteristics of study participants 41.0% female N = 345 59.0% male 345 patients (141 female, 204 male) Inclusion criteria: adult patients with KRASG12C-mutated advanced non-small cell lung cancer, who progressed after previous platinum-based chemotherapy and a programmed cell death protein-1 or programmed cell death-ligand 1 inhibitor Key exclusion criteria: new or progressing untreated brain lesions or symptomatic brain lesions, previously identified oncogenic driver mutation other than KRASG12C for which an approved therapy is available; previous treatment with docetaxel; previous treatment with a direct KRASG12C inhibitor; systemic anticancer therapy within 28 days of study day 1; and therapeutic or palliative radiation therapy within 2 weeks of treatment initiation Interventions N=171 sotorasib (an oral dose of 960 mg/day) N=174 docetaxel (an intravenous dose of 75 mg/m2 once every 3 weeks) P i t https://web.pathway.md/studies/rec2cxkYZ82BXlKkE 1/2 6/28/23, 12:28 AM CodeBreak 200 Pathway Primary outcome Median progression-free survival 5.6 months 5.6 4.5 4.2 months 2.8 months 1.4 months Significant increase 0.0 months Sotorasib Docetaxel Significant increase in median progression-free survival (5.6 months vs. 4.5 months; HR 1.515, 95% CI 1.16 to 1.96) Secondary outcomes Significant increase in overall response rate (28.1% vs. 13.2%; AD 14.8%, 95% CI 6.4 to 23.1) Safety outcomes No significant difference in treatment-emergent adverse events. Conclusion In adult patients with KRASG12C-mutated advanced non-small cell lung cancer, who progressed after previous platinum-based chemotherapy and a programmed cell death protein-1 or programmed cell death-ligand 1 inhibitor, sotorasib was superior to docetaxel with respect to median progression-free survival. Reference Adrianus Johannes de Langen, Melissa L Johnson, Julien Mazieres et al. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial. Lancet. 2023 Mar 4;401(10378):733-746. Open reference URL https://web.pathway.md/studies/rec2cxkYZ82BXlKkE 2/2