NIH announced Jan. 29 that “Basic Experimental Studies Involving Humans,” also called BESH, will no longer be considered clinical trials and will therefore no longer be subject to the requirements under the NIH definition of a clinical trial, including registration and reporting requirements in ClinicalTrials.gov.
The REZILIENT3 trial, a global phase III clinical trial evaluating the combination of zipalertinib and platinum-based chemotherapy compared with chemotherapy alone in the first-line treatment of adult patients with previously untreated, locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations, met its primary endpoint of progression-free survival at a planned interim analysis.
