Study of Durvalumab+Olaparib or Durvalumab after treatment with Durvalumab and chemotherapy in patients with lung cancer (ORION) - ORION

Study identifier:D9102C00001

ClinicalTrials.gov identifier:NCT03775486

EudraCT identifier:2018-003460-30

CTIS identifier:N/A

Recruitment Complete

Official Title

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)

Medical condition

Non-Small Cell Lung Cancer NSCLC

Phase

Phase 2

Healthy volunteers

No

Study drug

Durvalumab, Placebo for Olaparib, Olaparib, Nab-paclitaxel+carboplatin, Gemcitabine+carboplatin, Pemetrexed+carboplatin, Gemcitabine+cisplatin, Pemetrexed+cisplatin

Sex

All

Actual Enrollment

401

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 21 Dec 2018
Primary Completion Date: 11 Jan 2021
Estimated Study Completion Date: 27 Sept 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria