This case study involves a randomized Phase III study. It examined the study drug in combination with another medication versus chemotherapy in patients with checkpoint inhibitor refractory non-squamous NSCLC.

In this case study, you’ll learn:

  • PRA presented a data-driven rationale for the enrollment challenges the sponsor was facing
  • We did this by analyzing data intelligence assessing patterns by treatment line and utilizing our therapeutic expertise and local country standard of care knowledge
  • PRA worked with the sponsor to amend the protocol to align the inclusion/exclusion criteria with treatment patterns and the usual standard of care

This study proved crucially important to leverage data intelligence and collaborate early during protocol development to ensure feasible enrollment and study success. It produced a greater number of eligible patients, higher enrollment, and a more viable country mix.

Leveraging Immuno-Oncology Real World Data to Amend Non-Small Cell Lung Cancer Study Design

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