At a glance
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A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)
In Brief
A Phase 2 clinical trial evaluating Durvalumab, Placebo for Olaparib, and 6 other interventions for Non-small Cell Lung Cancer NSCLC. Active but no longer recruiting, targeting 401 participants across 68 sites in 12 countries.
Detailed Summary
This is a randomized, double-blind, multi-center, global Phase II study to determine the efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab monotherapy as maintenance therapy in patients whose disease has not progressed following Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
Study Details
Timeline
Interventions
Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.
Matching tablet
150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required
Standard of Care chemotherapy (squamous and non-squamous patients)
Standard of Care chemotherapy (squamous patients only)
Standard of Care chemotherapy (non-squamous patients only)
Standard of Care chemotherapy (squamous patients only)
Standard of Care chemotherapy (non-squamous patients only)