Ignite Creation Date:
2024-05-06 @ 7:29 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02542293
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2015-08-26
Brief Title:
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer NSCLC NEPTUNE
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Randomized Open-Label Multi-Center Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
NEPTUNE
Brief Summary:
This is a randomized open-label multi-center global Phase III study to determine the efficacy and safety of durvalumab tremelimumab combination therapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor EGFR and anaplastic lymphoma kinase ALK wild-type advanced or metastatic NSCLC
Detailed Description:
Patients will be randomized in a 11 to receive treatment with durvalumab tremelimumab combination therapy or SoC therapy The primary objective of this study is to assess the efficacy of combination treatment compared with SoC in terms of Overall Survival OS in patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2015-002197-21 | EUDRACT_NUMBER | None | None |