A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Summary

Participation Requirements

Description

This is a Phase II, open-label, multi-centre study to determine safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) monotherapy in participants with unresectable Stage III NSCLC who have not progressed following definitive, platinum-based sCRT. Approximately, 150 participants will be treated w...

This is a Phase II, open-label, multi-centre study to determine safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) monotherapy in participants with unresectable Stage III NSCLC who have not progressed following definitive, platinum-based sCRT. Approximately, 150 participants will be treated with the study drug in Europe and North America. Participants will be in complete response (CR), partial response (PR), or have stable disease (SD) following definitive, platinum-based sCRT, as assessed by the Investigator and further supported by the screening imaging radiological assessment. Participants must not have progressed following definitive, platinum-based sCRT; radiation therapy must be completed within 42 days prior to first Investigational product (IP) dose administration. Participants must have histologically- or cytologically-documented NSCLC and locally-advanced, unresectable Stage III disease. Participants will be treated with the study drug in 2 cohorts: approximately 100-120 participants in the World Health Organization/Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) 0 to 1 Cohort and up to 30 participants in the WHO/ECOG PS 2 Cohort.

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