OncRef

Clinical Trial: NCT03775486

Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2026-09-11

Study Overview

Brief 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.

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)

Conditions

Non-small Cell Lung Cancer NSCLC

Intervention / Treatment

  • Drug: Durvalumab
  • Drug: Placebo for Olaparib
  • Drug: Olaparib
  • Drug: Nab-paclitaxel+carboplatin
  • Drug: Gemcitabine+carboplatin
  • Drug: Pemetrexed+carboplatin
  • Drug: Gemcitabine+cisplatin
  • Drug: Pemetrexed+cisplatin

Other Study ID Numbers

  • D9102C00001
  • 2018-003460-30
  • 2018

Start Date (Actual)

2018-12-21

Primary Completion Date (Actual)

2021-01-11

Study Completion Date (Estimated)

2026-09-27

Enrollment (Actual)

401

Study Type

Interventional

Phase

Phase 2