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

NCT03775486 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2026-05-01

Study results available
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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.

Conditions

  • Non-small Cell Lung Cancer NSCLC

Interventions

DRUG

Durvalumab

Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.

DRUG

Placebo for Olaparib

Matching tablet

DRUG

Olaparib

150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required

DRUG

Nab-paclitaxel+carboplatin

Standard of Care chemotherapy (squamous and non-squamous patients)

DRUG

Gemcitabine+carboplatin

Standard of Care chemotherapy (squamous patients only)

DRUG

Pemetrexed+carboplatin

Standard of Care chemotherapy (non-squamous patients only)

DRUG

Gemcitabine+cisplatin

Standard of Care chemotherapy (squamous patients only)

DRUG

Pemetrexed+cisplatin

Standard of Care chemotherapy (non-squamous patients only)

Sponsors & Collaborators

Principal Investigators

  • Myung-Ju Ahn, MD · Sungkyunkwan University School of Medicine, 135-710, Seoul, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2021-01-11
Completion
2026-09-27
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Hungary
  • India
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775486 on ClinicalTrials.gov