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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDurvalumab and Placebo for Olaparib

Plus 6 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 11, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?68 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: AstraZeneca
Interventions being studied: Drug: Durvalumab; Drug: Placebo for Olaparib; Drug: Olaparib; Drug: Nab-paclitaxel+carboplatin; Drug: Gemcitabine+carboplatin; Drug: Pemetrexed+carboplatin; Drug: Gemcitabine+cisplatin; Drug: Pemetrexed+cisplatin

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

EGFR→ALK→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

\- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation. Patients must have tumors that lack activating EGFR mutations and ALK fusions.
(WHO)/(ECOG) performance status of 0 or 1
No prior chemotherapy or any other systemic therapy for Stage IV NSCLC
Adequate organ and marrow function without blood transfusions in the past 28 days,
At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1. Key Inclusion criteria for randomization to maintenance treatment:
Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy.
Creatinine Clearance (CrCl) ≥51 mL/min calculated by the investigator or designee using the Cockcroft-Gault equation or measured by 24-hour urine collection.
Ability to swallow whole oral medications.
All patients must provide a formalin-fixed, paraffin embedded tumor sample for tissue-based immunohistochemistry staining and DNA sequencing to determine PD-L1 expression, HRRm status, and other correlatives: either newly acquired or archival tumor samples (\<3 years old) are acceptable. If available, a newly acquired tumor biopsy, collected as part of routine clinical practice, is preferred. If not available, an archival sample taken \<3 years prior to screening is acceptable. If both an archival sample and a fresh tumor biopsy sample are available, both samples should be submitted for analysis and must be submitted as different samples using different accession numbers. Slides from different blocks cannot be mixed and submitted with the same kit.

Reasons someone may not be able to joinExclusion criteria

Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology.
Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5'diphosphoribose \[poly (ADP ribose)\] polymerase (PARP) therapy, or immunomediated therapy
Active or prior documented autoimmune or inflammatory disorders.
Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product (IP)
untreated (CNS) metastases and/or carcinomatous meningitis
Active infection.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research SiteBonita Springs, Florida
Research SiteSt. Petersburg, Florida
Research SiteTallahassee, Florida
Research SiteWest Palm Beach, Florida
Research SiteKansas City, Missouri
Research SiteBethlehem, Pennsylvania
Research SiteChattanooga, Tennessee
Research SiteNashville, Tennessee
Research SiteHouston, Texas
Research SiteAalst
Research SiteLeuven
Research SiteRoeselare

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 11, 2026. Always confirm current availability with the study team.

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