Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05469178
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2022-07-19
Brief Title:
A Study to Investigate the Safety Tolerability and Preliminary Anti-tumor Activity of Bemcentinib in Combination With Pembrolizumab Plus Pemetrexed and Carboplatin in Adult Participants With Untreated Non-squamous Non-small Cell Lung Cancer
Sponsor:
BerGenBio ASA
Organization:
BerGenBio ASA
Study Overview
Official Title:
Phase 1b2a Safety and Tolerability Study of Bemcentinib With PembrolizumabCarboplatinPemetrexed in Subjects With Untreated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer NSCLC WithoutWith a STK11 Mutation
Status:
RECRUITING
Status Verified Date:
2023-10
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:
The primary purpose of this study is to determine the safety and tolerability of the combination of bemcentinib with chemo-immunotherapy CIT to identify the recommended phase 2 dose RP2D when administered as first line 1L treatment in participants with locally advanced Stage IIIbIIIC or metastatic Stage IV non-squamous NSCLC with no actionable mutations and to determine the anti-tumor activity of the combination of bemcentinib with CIT when administered as 1L treatment in participants with locally advanced Stage IIIbIIIc or metastatic Stage IV non-squamous NSCLC with serinethreonine kinase 11 STK11 mutation and no actionable mutations
Detailed Description:
None
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 |
|---|---|---|---|
| 2019-003806-28 | EUDRACT_NUMBER | None | None |