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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.