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TerminatedNCT05469178Updated Oct 29, 2025Results posted

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

A Phase 1/2 interventional study of Bemcentinib and Pembrolizumab in Carcinoma, Non-Small-Cell Lung, sponsored by BerGenBio ASA. Terminated at 34 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-29.

Sponsored by BerGenBio ASA · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Lack of efficacy
Phase
Phase 1/2
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 26 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

BerGenBio ASA is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Phase 1b Cohort 1: Bemcentinib 75 mg

    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

  • Experimental
    Phase 1b Cohort 2: Bemcentinib 100 mg

    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

  • Experimental
    Phase 1b Cohort 3: Bemcentinib 150 mg

    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

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

    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

  • DrugBemcentinib

    Bemcentinib capsules will be administered daily orally.

  • DrugPembrolizumab

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

  • DrugPemetrexed

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

  • DrugCarboplatin

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Cycle 1 (the first 21 days of treatment)

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 12 months

07

Results

Posted Oct 29, 2025
Limitations and caveats
The study was terminated early due to lack of efficacy, therefore the study enrolled a smaller than planned number of participants.

Participant flow

Study recruitment was undertaken across 7 planned countries: USA, France, Greece, Hungary, Italy, Poland \& Spain. Of these countries, 5 countries enrolled participants: USA (10 participants), France (5 participants), Greece (3 participants), Italy (2 participants) \& Spain (6 participants). The recruitment process began in March 2023 and concluded in February 2025. 65 participants were screened in order to successfully recruit 26 participants.

Participant flow — Overall Study
MilestonePhase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)
Started33416
Completed0000
Not completed33416
Withdrew: Death1136
Withdrew: Lack of efficacy22110

Outcome measures

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

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

Time frame:
Cycle 1 (the first 21 days of treatment)
Reported as:
Count of participants · Participants
Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
ParticipantsPhase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mg
Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)000
PrimaryPhase 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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Phase 2a: Objective Response Rate (ORR) at 6 Months
ParticipantsPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)
Phase 2a: Objective Response Rate (ORR) at 6 Months0
PrimaryPhase 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.

Time frame:
12 months
Reported as:
Count of participants · Participants
Phase 2a: Objective Response Rate (ORR) at 12 Months
ParticipantsPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)
Phase 2a: Objective Response Rate (ORR) at 12 Months0

Adverse events

Collected over Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 1b Cohort 1: Bemcentinib 75 mg1/3 (33.3%)2/3 (66.7%)3/3 (100%)
Phase 1b Cohort 2: Bemcentinib 100 mg1/3 (33.3%)3/3 (100%)3/3 (100%)
Phase 1b Cohort 3: Bemcentinib 150 mg3/4 (75%)1/4 (25%)4/4 (100%)
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)6/16 (37.5%)6/16 (37.5%)15/16 (93.8%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventPhase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)
Claudication in Peripheral Vascular DiseaseVascular disorders1/30/30/40/16
Embolic StrokeNervous system disorders1/30/30/40/16
NauseaGastrointestinal disorders0/31/31/40/16
PancreatitisGastrointestinal disorders0/31/30/40/16
PyelonephritisInfections and infestations0/31/30/40/16
VomitingGastrointestinal disorders0/31/31/42/16
DyspneaRespiratory, thoracic and mediastinal disorders0/31/30/40/16
HypoxiaRespiratory, thoracic and mediastinal disorders0/31/30/40/16
Pleural EffusionRespiratory, thoracic and mediastinal disorders0/31/30/40/16
PneumoniaInfections and infestations0/31/30/40/16
Most frequent other events
Showing 10 of 156
Most frequent other events
EventPhase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)
NauseaGastrointestinal disorders3/32/34/42/16
AnemiaBlood and lymphatic system disorders1/31/34/41/16
Alanine Aminotransferase IncreasedInvestigations1/31/33/44/16
Aspartate Aminotransferase IncreasedInvestigations0/31/33/43/16
FatigueGeneral disorders2/31/31/41/16
InappetenceMetabolism and nutrition disorders2/31/32/44/16
Acid RefluxGastrointestinal disorders2/30/31/40/16
Back PainMusculoskeletal and connective tissue disorders1/32/30/42/16
Short of BreathRespiratory, thoracic and mediastinal disorders2/32/32/40/16
Feeling FrailGeneral disorders2/30/32/44/16

Baseline characteristics

This analysis population includes all 26 enrolled participants.

Age, Categorical
Age, Categorical(Participants)Phase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)Total
<=18 years00000
Between 18 and 65 years202913
>=65 years132713
Age, Continuous
Age, Continuous(Years)Phase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)Total
Mean52.0 ± 26.6671.0 ± 3.4663.8 ± 7.1461.2 ± 11.6762.4 ± 15.46
Sex: Female, Male
Sex: Female, Male(Participants)Phase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)Total
Female02035
Male3141321
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)Total
Hispanic or Latino12025
Not Hispanic or Latino1011315
Unknown or Not Reported11316
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)Total
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00011
White2141421
More than one race00000
Unknown or Not Reported12014
Region of Enrollment
Region of Enrollment(participants)Phase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)Total
Greece00033
United States221510
Italy00022
France11305
Spain00066
Weight
Weight(Kilograms)Phase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)Total
Median75.30 (63.0 to 81.6)82.00 (49.0 to 97.0)71.30 (61.2 to 82.2)70.50 (53.0 to 97.3)73.75 (49.0 to 97.0)
Height
Height(Centimetres)Phase 1b Cohort 1: Bemcentinib 75 mgPhase 1b Cohort 2: Bemcentinib 100 mgPhase 1b Cohort 3: Bemcentinib 150 mgPhase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)Total
Median172.00 (170.0 to 188.0)165.00 (162.6 to 172.0)173.00 (168.0 to 184.0)171.00 (157.5 to 183.0)171.50 (162.6 to 188.0)
08

Study locations

34 sites
  • Mount Sinai Comprehensive Cancer Center
    Miami Beach, Florida 33140, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland
    Baltimore, Maryland 21201, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • Duke University Medical Center - Duke Cancer Center
    Durham, North Carolina 27710, United States
  • Tennessee Oncology PLLC
    Nashville, Tennessee 37203, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Hôpital prive du Confluent SAS, Departement d'oncologie
    Nantes, 44277, France
  • Centre Antoine Lacassagne
    Nice, 6189, France
  • Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie
    Paris, 75015, France
  • Institut Gustave Roussy, Service de médecine
    Villejuif, 94805, France
  • Henry Dunant Hospital Center, 4th Oncology Department
    Athens, 115 26, Greece
  • Sotiria General Hospital of Chest Diseases, 3rd Department of Internal Medicine, Oncology Unit
    Athens, 115 27, Greece
  • General Hospital of Athens Alexandra, Department of the Clinical Therapeutics, Medical Oncology Unit
    Athens, 11528, Greece
  • University General Hospital of Larissa, Oncology Clinic
    Larissa, 41110, Greece
  • Semmelweis University- Department of Pulmonology
    Budapest, 1083, Hungary
  • Orszagos Koranyi Pulmonologiai Intezet
    Budapest, 1121, Hungary
  • Fejer County St. Gyorgy Hospital
    Székesfehérvár, 8000, Hungary
  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi
    Bologna, 40138, Italy
  • Ospedale San Luca
    Lucca, 55100, Italy
  • IRCCS - Istituto Europeo di Oncologia IEO
    Milan, 20141, Italy
  • IFO Regina Elena
    Rome, 144, Italy
  • Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, raka płuca i chorób wewnętrznych
    Bialystok, 15-540, Poland
  • Instytut Centrum Zdrowia Matki Polki (ICZMP)
    Lodz, 93-338, Poland
  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
    Lublin, 20090, Poland
  • MedPolonia Sp z oo
    Poznan, 60693, Poland
  • Hospital Universitari Germans Trias i Pujol
    Badalona, 8916, Spain
  • Hospital Universitario Vall d'Hebron
    Barcelona, 8035, Spain
  • MD Anderson Cancer Center, Oncology service
    Madrid, 28033, Spain
  • Hospital Universitario Ramon y Cajal
    Madrid, 28034, Spain
  • Hospital Universitario Fundacion Jimenez Diaz
    Madrid, 28040, Spain
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
  • Fundacion Instituto Valenciano de Oncologia (FIVO)
    Valencia, 46009, Spain
  • Hospital Clinico Universitario de Valencia
    Valencia, 46010, Spain
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 7, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05469178
Lead sponsor
BerGenBio ASA
Responsible party
Sponsor
First posted
Jul 21, 2022
Start date
Mar 3, 2023
Primary completion
Apr 3, 2025
Completion
Apr 3, 2025
Results posted
Oct 29, 2025
Last update
Oct 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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