Ignite Creation Date:
2024-05-06 @ 9:32 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03003962
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2016-12-15
Brief Title:
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer PEARL
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Randomized Open-Label Multi-Center Study of Durvalumab MEDI4736 Versus Standard of Care SoC Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer
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:
None
Brief Summary:
This is a randomized open-label multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor EGFR and anaplastic lymphoma kinase ALK wild-type and with PD-L1 high expression PEARL
Detailed Description:
Patients with stage IV NSCLC will be randomized in a 11 ratio to 2 treatment arms durvalumab or SOC therapy The dual primary objectives of this study are to assess the efficacy of durvalumab versus SoC in terms of OS Overall Survival in all randomized patients and in patients who are at low risk of EM early mortality
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 |
|---|---|---|---|
| 2018-001375-21 | EUDRACT_NUMBER | None | None |