CodeBreak 200
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
59.0% male
N = 345
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).
Primary outcome
Median progression-free survival
5.6 months
4.5 months
5.6 months
4.2 months
2.8 months
1.4 months
0.0 months
Sotorasib
Docetaxel
Significant
increase ▲
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.
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