Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)
Condition(s) studied
Investigational drug(s) / intervention(s)
Durvalumab: Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.
Placebo for Olaparib: Matching tablet
Olaparib: 150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required
Nab-paclitaxel+carboplatin: Standard of Care chemotherapy (squamous and non-squamous patients)
Gemcitabine+carboplatin: Standard of Care chemotherapy (squamous patients only)
Pemetrexed+carboplatin: Standard of Care chemotherapy (non-squamous patients only)
Gemcitabine+cisplatin: Standard of Care chemotherapy (squamous patients only)
Pemetrexed+cisplatin: Standard of Care chemotherapy (non-squamous patients only)
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.
Eligibility
Primary outcome measure(s)
- Progression-free Survival — From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
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).
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Bonita Springs | Florida | |
| Research Site | St. Petersburg | Florida | |
| Research Site | Tallahassee | Florida | |
| Research Site | West Palm Beach | Florida | |
| Research Site | Kansas City | Missouri | |
| Research Site | Bethlehem | Pennsylvania | |
| Research Site | Chattanooga | Tennessee | |
| Research Site | Nashville | Tennessee | |
| Research Site | Houston | Texas | |
| Research Site | Aalst | Belgium | |
| Research Site | Leuven | Belgium | |
| Research Site | Roeselare | Belgium | |
| Research Site | Budapest | Hungary | |
| Research Site | Budapest | Hungary | |
| Research Site | Debrecen | Hungary | |
| Research Site | Deszk | Hungary | |
| Research Site | Farkasgyepü | Hungary | |
| Research Site | Törökbálint | Hungary | |
| Research Site | Ahmedabad | India | |
| Research Site | Ahmedabad | India | |
| Research Site | Jamnagar | India | |
| Research Site | Kochi | India | |
| Research Site | Mysuru | India | |
| Research Site | Nashik | India | |
| Research Site | Nashik | India | |
| Research Site | Pune | India | |
| Research Site | Thiruvananthapuram | India | |
| Research Site | Chūōku | Japan | |
| Research Site | Kanazawa | Japan | |
| Research Site | Kurume-shi, | Japan | |
| Research Site | Matsuyama | Japan | |
| Research Site | Nagoya | Japan | |
| Research Site | Sendai | Japan | |
| Research Site | Sunto-gun | Japan | |
| Research Site | Ube-shi | Japan | |
| Research Site | Chihuahua City | Mexico | |
| Research Site | Culiacán | Mexico | |
| Research Site | San Luis Potosí City | Mexico | |
| Research Site | Blaricum | Netherlands | |
| Research Site | Harderwijk | Netherlands |
+ 28 more sites — see the full list on the official registry below.
More AstraZeneca trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03775486 on ClinicalTrials.gov ↗ ← All trials in South Korea