Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03164616
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2017-05-22
Brief Title:
Study of Durvalumab Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer POSEIDON
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Randomized Multi-Center Open-Label Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer NSCLC POSEIDON
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
POSEIDON
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 Standard of care SoC chemotherapy or durvalumab monotherapy SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic 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 metastatic NSCLC with tumors that lack activating EGFR mutations and ALK fusions are eligible for enrollment Patients will be randomized in a 111 ratio to receive treatment with durvalumab tremelimumab combination therapy SoC chemotherapy durvalumab monotherapy SoC chemotherapy or SoC chemotherapy alone Tumor evaluation scans will be performed until objective disease progression as efficacy assessment All patients will be followed for survival until the end of the study An independent data monitoring committee IDMC composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule
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 |
|---|---|---|---|
| 2017-000920-81 | EUDRACT_NUMBER | None | None |