TerminatedPhase 1 / Phase 2NCT05469178

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

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.

Checked against the public recordLast updated Oct 29, 2025 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1 / Phase 2
U.S. locations34
SponsorBerGenBio ASA
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
BerGenBio ASA
Interventions being studied
Drug: Bemcentinib; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Main Inclusion Criteria: * Histologically-confirmed or cytologically confirmed diagnosis of advanced (Stage IIIb/IIIc) or metastatic (Stage IV) (AJCC Edition 8) non-squamous NSCLC not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (Phase 1b) targetable with first-line treatment. * Histologically-confirmed or cytologically confirmed diagnosis of stage of advanced (Stage IIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11 mutation, not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (phase 2a) targetable with first-line treatment. * Have not received prior systemic treatment for their advanced/metastatic NSCLC * Have measurable disease per RECIST 1.1 as assessed by the investigator Main Exclusion Criteria: * Has received any prior chemotherapy or biological therapy for locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) adenocarcinoma of the lung * Received radiation therapy within 2 weeks prior to starting study treatment or has not recovered (i.e. \<=Grade 1 at baseline) from AEs due to a previous radiation therapy * Major surgery within 28 days prior to start of study treatment and failure to have recovered adequately from the complications of the surgery/intervention prior to the first dose of study treatment

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
  • University of ChicagoChicago, Illinois
  • Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of MarylandBaltimore, Maryland
  • Icahn School of Medicine at Mount SinaiNew York, New York
  • Duke University Medical Center - Duke Cancer CenterDurham, North Carolina
  • Tennessee Oncology PLLCNashville, Tennessee
  • UT Southwestern Medical CenterDallas, Texas
  • Hôpital prive du Confluent SAS, Departement d'oncologieNantes
  • Centre Antoine LacassagneNice
  • Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologieParis
  • Institut Gustave Roussy, Service de médecineVillejuif
  • Henry Dunant Hospital Center, 4th Oncology DepartmentAthens

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 29, 2025. Always confirm current availability with the study team.

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