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NCT03775486 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by AstraZeneca.

Active
Registry status
Phase 2
Development phase
401
Enrollment target
20
Study locations

NCT03775486 is a Phase 2 study of Non-small Cell Lung Cancer (NSCLC) that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 401 participants, above the 282-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT03775486, a Phase 2 study of Non-small Cell Lung Cancer (NSCLC), is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
401 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

Interventions

  • DRUG Olaparib
  • DRUG Durvalumab
  • DRUG Placebo for Olaparib
  • DRUG Nab-paclitaxel+carboplatin
  • DRUG Gemcitabine+carboplatin

Study Locations (20)

Other

  • Research Site - Aalst
  • Research Site - Leuven
  • Research Site - Roeselare
  • Research Site - Budapest
  • Research Site - Budapest
  • Research Site - Debrecen
  • Research Site - Deszk
  • Research Site - Farkasgyepü
  • Research Site - Törökbálint
  • Research Site - Ahmedabad
  • Research Site - Ahmedabad

Florida

  • Research Site - Bonita Springs
  • Research Site - St. Petersburg
  • Research Site - Tallahassee
  • Research Site - West Palm Beach

Tennessee

  • Research Site - Chattanooga
  • Research Site - Nashville

Missouri

  • Research Site - Kansas City

Pennsylvania

  • Research Site - Bethlehem

Texas

  • Research Site - Houston

Trial Details

FieldValue
Enrollment Target 401 participants
Start Date 2018-12-21
Est. Completion 2026-09-27
Phase Phase 2

Sponsor

AstraZeneca

1,285 total trials

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What the Registry Record Tells You About NCT03775486

The ClinicalTrials.gov registry entry for NCT03775486 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 401 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 282-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (42% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 5 interventions - of which Olaparib is the first listed.

NCT03775486 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, Florida, Tennessee.

Frequently Asked Questions

What is clinical trial NCT03775486 about?

NCT03775486 is a clinical study titled "Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)". 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) plati...

What is the current status of trial NCT03775486?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 401 participants. The study started on 2018-12-21. Estimated completion is 2026-09-27.

What conditions does trial NCT03775486 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT03775486?

The interventions under investigation include: Olaparib (DRUG), Durvalumab (DRUG), Placebo for Olaparib (DRUG), Nab-paclitaxel+carboplatin (DRUG), Gemcitabine+carboplatin (DRUG).

Who is sponsoring clinical trial NCT03775486?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03775486 being conducted?

This trial has 20 study locations across Florida, Missouri, Pennsylvania, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.