Skip to content

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 NonSmall Cell Lung Cancer (ORION)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512769-16-00
Acronym
D9102C00001
Enrollment
80
Registered
2024-10-07
Start date
2018-11-14
Completion date
2025-01-28
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV Non Small Cell Lung Cancer whose tumors lack EGFR mutations and ALK fusions

Brief summary

Progression-free survival (PFS) defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment using RECIST 1.1 or death (by any cause in the absence of progression)

Detailed description

Overall survival (OS) defined as time from date of randomization until the date of death by any cause, Objective response rate (ORR) defined as percentage of patients with an Investigator-assessed response of CR or PR after randomization, Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression, PFS in HRRm population defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment in HRRm population using RECIST 1.1 or death (by any cause in the absence of progression), Concentration of durvalumab, Disease-related symptoms and HRQoL assessed by change from baseline and time to deterioration (for maintenance phase)in EORTC QLQ-C30 and EORTC QLQ-LC13, Presence of anti-drug antibodies (ADA) for durvalumab, Safety endpoints of AEs, physical examinations, laboratory findings, and vital signs

Interventions

DRUGLynparza 150 mg film-coated tablets
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS) defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment using RECIST 1.1 or death (by any cause in the absence of progression)

Secondary

MeasureTime frame
Overall survival (OS) defined as time from date of randomization until the date of death by any cause, Objective response rate (ORR) defined as percentage of patients with an Investigator-assessed response of CR or PR after randomization, Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression, PFS in HRRm population defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment in HRRm population using RECIST 1.1 or death (by any cause in the absence of progression), Concentration of durvalumab, Disease-related symptoms and HRQoL assessed by change from baseline and time to deterioration (for maintenance phase)in EORTC QLQ-C30 and EORTC QLQ-LC13, Presence of anti-drug antibodies (ADA) for durvalumab, Safety endpoints of AEs, physical examinations, laboratory find

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026