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

NCT05469178 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: BGBC0162024 511007 41 00U1111-1312-8770
• Study Type: interventional
• Target: 26
• Locations: 7 countries
• Sites: 34

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (3)

• Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)

  DLT graded using NCI CTCAE Version 5.0 based on the Investigator assessment.

  Cycle 1 (the first 21 days of treatment)

• Phase 2a: Objective Response Rate (ORR) at 6 Months

  ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.

  6 months

• Phase 2a: Objective Response Rate (ORR) at 12 Months

  ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.

  12 months

Study Arms (4)

Phase 1b Cohort 1: Bemcentinib 75 mg

EXPERIMENTAL

Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 75 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).

Drug: Bemcentinib; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin

Phase 1b Cohort 2: Bemcentinib 100 mg

EXPERIMENTAL

Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 100 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).

Drug: Bemcentinib; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin

Phase 1b Cohort 3: Bemcentinib 150 mg

EXPERIMENTAL

Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 150 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).

Drug: Bemcentinib; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin

Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)

EXPERIMENTAL

Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib second dose, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).

Drug: Bemcentinib; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin

Interventions

Bemcentinib DRUG

Bemcentinib capsules will be administered daily orally.

Phase 1b Cohort 1: Bemcentinib 75 mg; Phase 1b Cohort 2: Bemcentinib 100 mg; Phase 1b Cohort 3: Bemcentinib 150 mg; Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)

Pembrolizumab DRUG

Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.

Phase 1b Cohort 1: Bemcentinib 75 mg; Phase 1b Cohort 2: Bemcentinib 100 mg; Phase 1b Cohort 3: Bemcentinib 150 mg; Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)

Pemetrexed DRUG

Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.

Phase 1b Cohort 1: Bemcentinib 75 mg; Phase 1b Cohort 2: Bemcentinib 100 mg; Phase 1b Cohort 3: Bemcentinib 150 mg; Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)

Carboplatin DRUG

Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.

Phase 1b Cohort 1: Bemcentinib 75 mg; Phase 1b Cohort 2: Bemcentinib 100 mg; Phase 1b Cohort 3: Bemcentinib 150 mg; Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BerGenBio ASA: lead

Study Sites (34)

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Hôpital prive du Confluent SAS, Departement d'oncologie

Nantes, 44277, France

Location

Centre Antoine Lacassagne

Nice, 6189, France

Location

Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie

Paris, 75015, France

Location

Institut Gustave Roussy, Service de médecine

Villejuif, 94805, France

Location

Henry Dunant Hospital Center, 4th Oncology Department

Athens, 115 26, Greece

Location

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

Athens, 115 27, Greece

Location

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

Athens, 11528, Greece

Location

University General Hospital of Larissa, Oncology Clinic

Larissa, 41110, Greece

Location

Semmelweis University- Department of Pulmonology

Budapest, 1083, Hungary

Location

Orszagos Koranyi Pulmonologiai Intezet

Budapest, 1121, Hungary

Location

Fejer County St. Gyorgy Hospital

Székesfehérvár, 8000, Hungary

Location

Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

Ospedale San Luca

Lucca, 55100, Italy

Location

IRCCS - Istituto Europeo di Oncologia IEO

Milan, 20141, Italy

Location

IFO Regina Elena

Rome, 144, Italy

Location

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

Bialystok, 15-540, Poland

Location

Instytut Centrum Zdrowia Matki Polki (ICZMP)

Lodz, 93-338, Poland

Location

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20090, Poland

Location

MedPolonia Sp z oo

Poznan, 60693, Poland

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 8916, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 8035, Spain

Location

MD Anderson Cancer Center, Oncology service

Madrid, 28033, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Fundacion Instituto Valenciano de Oncologia (FIVO)

Valencia, 46009, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

bemcentinib; pembrolizumab; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Limitations and Caveats

The study was terminated early due to lack of efficacy, therefore the study enrolled a smaller than planned number of participants.

Results Point of Contact

• Title: BerGenBio Clinical Team
• Organization: BerGenBio ASA

registry.postings@bergenbio.com

+47 559 61 159

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: March 3, 2023
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); ES (8); GR (4); US (7); FR (4); HU (3); IT (4)