Viewing Study NCT05469178



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