CASE STUDY Leveraging Immuno-Oncology Real World Data to Amend Non-Small Cell Lung Cancer Study DesignLeveraging Immuno-Oncology Real World Data to Amend Non-Small Cell Lung Cancer Study Design ABSTRACT The original protocol developed by the sponsor deviated from the global non-small cell lung cancer (NSCLC) standard of care (SOC), which limited the number of participating countries and led to low enrollment. PRA worked with the sponsor to leverage our data intelligence and amend the protocol to align inclusion/exclusion criteria to the global SOC treatment patterns, resulting in a higher enrollment rate and a more extensive country selection. STUDY DESCRIPTION A randomized Phase III study examined the study drug in combination with nivolumab vs chemotherapy in patients with che

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