Single-arm study design and its applicationdoi:10.1093/annonc/mdx586Kenichi YoshimuraAnnals of Oncology
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In an ongoing, open-label, single-arm phase II study ( NCT02927301 ), 181 patients with untreated, resectable, stage IB–IIIB non-small cell lung cancer received two doses of neoadjuvant atezolizumab monotherapy. The primary end point was major pathologi
Shimatsu A, Sauter N, Kelly RY, Unge P, Zhi X, Fleseriu M (2015) Study design of a phase III, multicenter, double-blind, randomized withdrawal study following a 24-week, single-arm, open-label osilodrostat (LCI699) treatment to evaluate the long- term safety and efficacy of osilodro...
There are some limitations in this study. Firstly, the current study adopted single-arm design with limited sample size, and only Chinese patients were enrolled. Secondly, biomarker analysis might provide more information to identify who can derive more benefits from this combination, but such analys...
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Lastly, the absence of a control group in the single-arm studies analyzed in this paper makes the results less convincing than those from controlled clinical trials. Conclusion In conclusion, this single-arm study shows that PDT may be an effective treatment option for oral leukoplakia, ...