Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03775486
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2018-11-27
Brief Title:
Study of DurvalumabOlaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer ORION
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase II Randomized Multi-Center Double-Blind Global 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 Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer ORION
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORION
Brief 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
Detailed Description:
Adult patients with a histologically or cytologically documented advanced NSCLC not amenable to curative surgery or radiation with tumors that lack activation EGFR mutations and ALK fusions are eligible for enrollment During the initial therapy phase patients will receive treatment with Durvalumab along with the Investigators choice of platinum-based doublet therapy for squamous NSCLC nab-paclitaxel plus carboplatin or gemcitabine plus carboplatincisplatin and non-squamous NSCLC nab-paclitaxel plus carboplatin or pemetrexed plus carboplatincisplatin for 4 cycles Patients who have completed 4 cycles and not progressed throughout the initial therapy phase will be randomized in a 11 ratio into the maintenance phase of the study to receive either Durvalumab plus placebo or Durvalumab plus Olaparib maintenance therapy Patients will receive maintenance treatment until specific discontinuation criteria are met including clinical disease progression as assessed by the Investigator or RECIST 11-defined radiological Progressive Disease PD unacceptable toxicity and withdrawal of consent Tumor evaluation scans will be performed until objective disease progression as efficacy assessments All patients will be followed for survival until the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-003460-30 | EUDRACT_NUMBER | None | None |