Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02352948
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2015-01-28
Brief Title:
A Global Study to Assess the Effects of MEDI4736 Durvalumab Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Open Label Randomised Multi-centre International Study of MEDI4736 Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Stage IIIB-IV Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements ARCTIC
Status:
COMPLETED
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:
ARCTIC
Brief Summary:
This study is a Phase III randomised open label multi-centre study assessing the efficacy and safety of MEDI4736 durvalumab versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 durvalumab plus tremelimumab MEDI4736treme versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC Stage IIIB-IV who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC Patients with known EGFR Epidermal growth factor receptor tyrosine kinase TK activating mutations and anaplastic lymphoma kinase ALK rearrangements are not eligible for the study prospective testing is not planned within this study The Standard of Care options are an EGFR tyrosine kinase inhibitor erlotinib TARCEVA gemcitabine or vinorelbine NAVELBINE
Detailed Description:
The study has an umbrella design with 2 sub-studies sub-study A randomizing patients with PD-L1 positive tumours 11 into MEDI4736 durvalumab vs Standard of Care and sub-study B randomizing patients with PD-L1 negative tumours 2312 into MEDI4736 durvalumab vs MEDI4736 durvalumab plus tremelimumab vs tremelimumab vs Standard of Care The two substudies may have different durations of recruitment periods due to differences in patient population PD-L1 expression They may not run concurrently with start and completion of recruitment potentially occurring at different time points
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 |
|---|---|---|---|
| 2014-000338-46 | EUDRACT_NUMBER | None | None |