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Validating ORR and PFS as surrogate endpoints in phase II and III clinical trials for NSCLC patients: Difference exists in the strength of surrogacy in various trial settings

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This study aims to systematically validate the performance of surrogate endpoints in phase II and III clinical trials for NSCLC patients under various trial settings. A literature search retrieved all registered phase II and III trials of NSCLC patients in which OS, with at least one of ORR and PFS, were reported. Associations between surrogate and true endpoints were assessed on two levels.