Clinical trial NCT05469178: 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
Official title: Phase 1b/2a Safety and Tolerability Study of Bemcentinib With Pembrolizumab/Carboplatin/Pemetrexed in Subjects With Untreated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Without/With a STK11 Mutation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: BerGenBio ASA
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Phase 1b: Incidence of Dose Limiting Toxicity (DLT)
timeFrame: Cycle 1 (the first 21 days of treatment)
measure: Phase 2a: Objective Response Rate (ORR) at 6 Months
timeFrame: 6 months
measure: Phase 2a: Objective Response Rate (ORR) at 12 Months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland
state: Maryland
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University Medical Center - Duke Cancer Center
state: North Carolina
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Nantes Cedex 2
country: France
facility: Hôpital prive du Confluent SAS, Departement d'oncologie
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie
city: Villejuif
country: France
facility: Institut Gustave Roussy, Service de médecine
city: Athens
country: Greece
facility: Henry Dunant Hospital Center, 4th Oncology Department
city: Athens
country: Greece
facility: Sotiria General Hospital of Chest Diseases, 3rd Department of Internal Medicine, Oncology Unit
city: Athens
country: Greece
facility: General Hospital of Athens Alexandra, Department of the Clinical Therapeutics, Medical Oncology Unit
city: Larissa
country: Greece
facility: University General Hospital of Larissa, Oncology Clinic
city: Budapest
country: Hungary
facility: Semmelweis University- Department of Pulmonology
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Szekesfehervar
country: Hungary
facility: Fejer County St. Gyorgy Hospital
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi
city: Lucca
country: Italy
facility: Ospedale San Luca
city: Milan
country: Italy
facility: IRCCS - Istituto Europeo di Oncologia IEO
city: Rome
country: Italy
facility: IFO Regina Elena
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, raka płuca i chorób wewnętrznych
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki (ICZMP)
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
city: Poznan
country: Poland
facility: MedPolonia Sp z oo
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: MD Anderson Cancer Center, Oncology service
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia (FIVO)
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
References: