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

Last updated: May 6, 2025
Sponsor: BerGenBio ASA
Overall Status: Terminated

Phase

1/2

Condition

N/A

Treatment

Carboplatin

Bemcentinib

Pemetrexed

Clinical Study ID

NCT05469178
BGBC016
2019-003806-28
2024 511007 41 00
U1111-1312-8770
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Histologically-confirmed or cytologically confirmed diagnosis of advanced (StageIIIb/IIIc) or metastatic (Stage IV) (AJCC Edition 8) non-squamous NSCLC not amenableto 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 withSTK11 mutation, not amenable to curative therapy, irrespective of PD-L1 status andwithout 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

Exclusion

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 hasnot recovered (i.e. <=Grade 1 at baseline) from AEs due to a previous radiationtherapy

  • Major surgery within 28 days prior to start of study treatment and failure to haverecovered adequately from the complications of the surgery/intervention prior to thefirst dose of study treatment

Study Design

Total Participants: 26
Treatment Group(s): 4
Primary Treatment: Carboplatin
Phase: 1/2
Study Start date:
March 06, 2023
Estimated Completion Date:
April 03, 2025

Connect with a study center

  • Hopital prive du Confluent SAS, Departement d'oncologie

    Nantes Cedex 2, 44277
    France

    Active - Recruiting

  • Hôpital prive du Confluent SAS, Departement d'oncologie

    Nantes Cedex 2, 44277
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 6189
    France

    Site Not Available

  • Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie

    Paris, 75015
    France

    Site Not Available

  • Institut Gustave Roussy, Service de médecine

    Villejuif, 94805
    France

    Site Not Available

  • General Hospital of Athens Alexandra, Department of the Clinical Therapeutics, Medical Oncology Unit

    Athens, 11528
    Greece

    Site Not Available

  • Henry Dunant Hospital Center, 4th Oncology Department

    Athens, 115 26
    Greece

    Site Not Available

  • Sotiria General Hospital of Chest Diseases, 3rd Department of Internal Medicine, Oncology Unit

    Athens, 115 27
    Greece

    Site Not Available

  • University General Hospital of Larissa, Oncology Clinic

    Larissa, 41110
    Greece

    Site Not Available

  • Orszagos Koranyi Pulmonologiai Intezet

    Budapest, 1121
    Hungary

    Site Not Available

  • Semmelweis University- Department of Pulmonology

    Budapest, 1083
    Hungary

    Site Not Available

  • Fejer County St. Gyorgy Hospital

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Ospedale San Luca

    Lucca, 55100
    Italy

    Site Not Available

  • IRCCS - Istituto Europeo di Oncologia IEO

    Milan, 20141
    Italy

    Site Not Available

  • IFO Regina Elena

    Rome, 144
    Italy

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, raka płuca i chorób wewnętrznych

    Bialystok, 15-540
    Poland

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki (ICZMP)

    Lodz, 93-338
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20090
    Poland

    Site Not Available

  • MedPolonia Sp z oo

    Poznan, 60693
    Poland

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 8916
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • MD Anderson Cancer Center, Oncology service

    Madrid, 28033
    Spain

    Site Not Available

  • Fundacion Instituto Valenciano de Oncologia (FIVO)

    Valencia, 46009
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Duke University Medical Center - Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Tennessee Oncology PLLC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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