drugset / Trial / 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
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2023-03-03
- Primary completion
- 2025-04-03
- Completion
- 2025-04-03
Outcome
Outcome not reported
Stopped: “Lack of efficacy”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bemcentinib | Small molecule | 75 mg | Oral |
| Subject | Bemcentinib | Small molecule | 100 mg | Oral |
| Subject | Bemcentinib | Small molecule | 150 mg | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |