BACKGROUND: Anti-angiogenic agents, such as nintedanib and ramucirumab, when combined with docetaxel, are subsequent treatment options in patients with non-small cell lung cancer (NSCLC) who have failed on first-line chemotherapy or immunochemotherapy. However, to date, there are no validated predictive biomarkers for efficacy of anti-angiogenic therapies in this setting. The aim of this study was to explore whether genetic or genomic markers, alone or combined with clinical covariates, could be used to predict overall survival (OS) in patients with NSCLC who are eligible for treatment with nintedanib plus docetaxel. METHODS: LUME-BioNIS (NCT02671422) was a prospective, non-interventional study that assessed the efficacy and safety of nintedanib plus docetaxel in patients with relapsed/refractory NSCLC. The primary outcome was OS in relation to exploratory molecular biomarkers, alone or in combination with clinical covariates. Exploratory multivariate and univariate analyses were undertaken on putative biomarkers including clinical variables, somatic mutations, gene expression, immunological, and proliferation markers. Sub-analyses in patients with prior immunotherapy were performed. RESULTS: Of 260 enrolled patients, most patients received nintedanib plus docetaxel in the second-line (68.8%) or third-line (25.8%). After a median follow-up of 19.7 months, median OS was 8.1 months (95% confidence interval: 7.1-9.5). Univariate subgroup analysis indicated that the presence of liver/adrenal metastases, Eastern Cooperative Oncology Group performance status (ECOG PS)
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