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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

NCT05469178 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-10-29

Study results available
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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

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.

Sponsors & Collaborators

  • BerGenBio ASA

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2025-04-03
Completion
2025-04-03
FDA Drug
Yes

Countries

  • United States
  • France
  • Greece
  • Hungary
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469178 on ClinicalTrials.gov