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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: Active Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by AstraZeneca.
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 278-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1. PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 401 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2026-09-27 |
| Phase | Phase 2 |
What the registry record for NCT03775486 still lists
NCT03775486 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, above the 278-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (44% higher).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
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Where NCT03775486's enrollment target sits among peer trials
401 14th of 59 higher than 46 of 59 other Non-small Cell Lung Cancer (NSCLC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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