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Durvalumab + Olaparib for Non-Small Cell Lung Cancer (ORION Trial)

Phase 2
Waitlist Available
Led By Myung-Ju Ahn, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior chemotherapy or any other systemic therapy for Stage IV NSCLC
Ability to swallow whole oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from start of initial therapy up to 2 years.
Awards & highlights

ORION Trial Summary

This trialstudies if adding a drug to Durvalumab can help people with advanced NSCLC and no EGFR/ALK mutations after chemotherapy.

Who is the study for?
This trial is for Stage IV non-small cell lung cancer patients without certain genetic mutations, who've had no prior systemic therapy and responded to initial chemo with Durvalumab. They must be able to perform daily activities with little or no assistance, swallow pills, and have proper kidney function and organ health.Check my eligibility
What is being tested?
The ORION study tests if adding Olaparib to Durvalumab maintenance therapy is more effective than Durvalumab alone after initial chemo in advanced lung cancer patients. It's a global Phase II trial where participants are randomly assigned treatment options in a blinded manner.See study design
What are the potential side effects?
Durvalumab may cause immune-related issues like inflammation of organs, while Olaparib can lead to blood cell count changes, nausea, fatigue, respiratory infections and potential allergic reactions. Side effects vary among individuals.

ORION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received any treatment for stage IV non-small cell lung cancer.
Select...
I can swallow pills whole.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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I have at least one tumor that can be measured and has not been treated with radiation.
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My cancer does not have EGFR mutations or ALK fusions.
Select...
My kidney function, measured by creatinine clearance, is good.
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My lung cancer is at stage IV and cannot be cured with surgery or radiation.

ORION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from start of initial therapy up to 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from start of initial therapy up to 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival
Secondary outcome measures
Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
Concentration of Durvalumab
+8 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

ORION Trial Design

2Treatment groups
Experimental Treatment
Group I: Durvalumab/Olaparib Combination TherapyExperimental Treatment7 Interventions
Durvalumab/Olaparib Combination Therapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/Olaparib (maintenance phase)
Group II: Durvalumab MonotherapyExperimental Treatment7 Interventions
Durvalumab Monotherapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/placebo (maintenance phase)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,501 Total Patients Enrolled
Myung-Ju Ahn, MDPrincipal InvestigatorSungkyunkwan University School of Medicine, 135-710, Seoul, Korea
2 Previous Clinical Trials
588 Total Patients Enrolled

Media Library

Olaparib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03775486 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)
2018. "Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03775486.
All > Lynparza
~63 spots leftby Apr 2025
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