Ignite Creation Date:
2024-05-06 @ 4:06 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02453282
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2015-05-20
Brief Title:
Phase III Open Label First Line Therapy Study of MEDI 4736 Durvalumab With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer NSCLC
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 or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer NSCLCMYSTIC
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:
MYSTIC
Brief Summary:
This is a randomized open-label multi-center global Phase III study to determine the efficacy and safety of MEDI4736 tremelimumab combination therapy and MEDI4736 monotherapy 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 locally advanced or metastatic NSCLC
Detailed Description:
Patients will be randomized in a 111 ratio to receive treatment with MEDI4736 tremelimumab combination therapy MEDI4736 monotherapy or Standard of Care SoC therapy
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 |
|---|---|---|---|
| 2015-001279-39 | EUDRACT_NUMBER | None | None |