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
Stopped early · Phase 1/Phase 2
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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.
Key facts
- Study ID
- NCT05469178
- Run by
- BerGenBio ASA
- People needed
- 26
- Starts
- 2023-03-03
- Expected to finish
- 2025-04-03
- Last updated by the study team
- 2025-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
- University of Chicago — Chicago, Illinois, United States
- Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland — Baltimore, Maryland, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Duke University Medical Center - Duke Cancer Center — Durham, North Carolina, United States
- Tennessee Oncology PLLC — Nashville, Tennessee, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- Hôpital prive du Confluent SAS, Departement d'oncologie — Nantes, France
- Centre Antoine Lacassagne — Nice, France
- Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie — Paris, France
- Institut Gustave Roussy, Service de médecine — Villejuif, France
- Henry Dunant Hospital Center, 4th Oncology Department — Athens, Greece
- Sotiria General Hospital of Chest Diseases, 3rd Department of Internal Medicine, Oncology Unit — Athens, Greece
- General Hospital of Athens Alexandra, Department of the Clinical Therapeutics, Medical Oncology Unit — Athens, Greece
- University General Hospital of Larissa, Oncology Clinic — Larissa, Greece
- Semmelweis University- Department of Pulmonology — Budapest, Hungary
- Orszagos Koranyi Pulmonologiai Intezet — Budapest, Hungary
- Fejer County St. Gyorgy Hospital — Székesfehérvár, Hungary
- Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi — Bologna, Italy
- Ospedale San Luca — Lucca, Italy
- IRCCS - Istituto Europeo di Oncologia IEO — Milan, Italy
- IFO Regina Elena — Rome, Italy
- Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, raka płuca i chorób wewnętrznych — Bialystok, Poland
- Instytut Centrum Zdrowia Matki Polki (ICZMP) — Lodz, Poland
- Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie — Lublin, Poland
Full record on ClinicalTrials.gov
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