At a glance
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A Phase II, Open-label, Multicenter, International Study of Durvalumab Following Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Durvalumab for Non-small Cell Lung Cancer. Completed, enrolled 102 participants across 35 sites in 6 countries.
Detailed Summary
This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy \[60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)\]; Cohort B: palliative radiation therapy \[40 to \< 54 Gy or hypofractionated BED\])
Study Details
Timeline
Interventions
All patients will receive 1500 mg durvalumab via IV infusion q4w for up to a maximum of 12 months.