NCT05469178

A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell Lung Cancer Patients With a Mutation in the STK11 Gene

Phase 1b/2a Safety and Tolerability Study of Bemcentinib With Pembrolizumab/Carboplatin/Pemetrexed in Subjects With Untreated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Without/With a STK11 Mutation

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: BerGenBio ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 IIIb/IIIC) 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 IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC with serine/threonine kinase 11 (STK11) mutation and no actionable mutations.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Bemcentinib	Bemcentinib capsules will be administered daily orally.
DRUG	Pembrolizumab	Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
DRUG	Pemetrexed	Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
DRUG	Carboplatin	Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.

Timeline

• Start date: 2023-03-03
• Primary completion: 2025-04-03
• Completion: 2025-04-03
• First posted: 2022-07-21
• Last updated: 2025-10-29
• Results posted: 2025-10-29

Locations

34 sites across 7 countries: United States, France, Greece, Hungary, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study