Carcinoma, Non-Small-Cell LungPhase 1/2NCT05469178

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 study testing Bemcentinib, Pembrolizumab and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by BerGenBio ASA at 34 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: Bemcentinib, Pembrolizumab and Pemetrexed
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 34 sitesin 7 countries
Study dates: 3 Mar 2023to 3 Apr 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

34 sites in 7 countries.

Country

City, postcode or hospital

34 sites in 7 countries

Spain8 sites

Hospital Universitari Germans Trias i Pujol
Badalona, 8916
Hospital Universitario Vall d'Hebron
Barcelona, 8035
MD Anderson Cancer Center, Oncology service
Madrid, 28033
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Fundacion Instituto Valenciano de Oncologia (FIVO)
Valencia, 46009
Hospital Clinico Universitario de Valencia
Valencia, 46010

Other trials in Spain

United States7 sites

Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland
Baltimore, Maryland, 21201
University of Chicago
Chicago, Illinois, 60637
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, 27710
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

France4 sites

Hôpital prive du Confluent SAS, Departement d'oncologie
Nantes, 44277
Centre Antoine Lacassagne
Nice, 6189
Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie
Paris, 75015
Institut Gustave Roussy, Service de médecine
Villejuif, 94805

Other trials in France

Greece4 sites

Henry Dunant Hospital Center, 4th Oncology Department
Athens, 115 26
Sotiria General Hospital of Chest Diseases, 3rd Department of Internal Medicine, Oncology Unit
Athens, 115 27
General Hospital of Athens Alexandra, Department of the Clinical Therapeutics, Medical Oncology Unit
Athens, 11528
University General Hospital of Larissa, Oncology Clinic
Larissa, 41110

Other trials in Greece

Italy4 sites

Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi
Bologna, 40138
Ospedale San Luca
Lucca, 55100
IRCCS - Istituto Europeo di Oncologia IEO
Milan, 20141
IFO Regina Elena
Rome, 144

Other trials in Italy

Poland4 sites

Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, raka płuca i chorób wewnętrznych
Bialystok, 15-540
Instytut Centrum Zdrowia Matki Polki (ICZMP)
Lodz, 93-338
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20090
MedPolonia Sp z oo
Poznan, 60693

Other trials in Poland

Hungary3 sites

Semmelweis University- Department of Pulmonology
Budapest, 1083
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121
Fejer County St. Gyorgy Hospital
Székesfehérvár, 8000

Other trials in Hungary

About this study

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

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
Being tested: Bemcentinib, Pembrolizumab, Pemetrexed, Carboplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BemcentinibDrug
Bemcentinib capsules will be administered daily orally.
PembrolizumabDrug
Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
PemetrexedDrug
Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
CarboplatinDrug
Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.

Study groups in NCT05469178
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Bemcentinib; Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
DLT graded using NCI CTCAE Version 5.0 based on the Investigator assessment.
Measured: 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.
Measured: 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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 20233 Apr 2025

First posted21 Jul 2022
Study start3 Mar 2023
Primary completion3 Apr 2025
Study completion3 Apr 2025

Why it stopped: Lack of efficacy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05469178
Sponsor's protocol ID: BGBC016
Other IDs: 2024 511007 41 00, U1111-1312-8770
Status last verified: Oct 2025
First submitted: 19 Jul 2022
Last updated: 29 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05469178
Acronym / sponsor ID: BGBC016
Conditions: Carcinoma, Non-Small-Cell Lung
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of efficacy
Enrolment: 26 participants (actual)
Lead sponsor: BerGenBio ASAIndustry (pharma, biotech, devices)
Study start: 3 Mar 2023 (actual)
Primary completion: 3 Apr 2025 (actual)
Study completion: 3 Apr 2025 (actual)
First posted: 21 Jul 2022 (actual)
Results: Posted 29 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1b Cohort 1: Bemcentinib 75 mg	Experimental	Drug: Bemcentinib, Drug: Pembrolizumab, Drug: Pemetrexed, Drug: CarboplatinParticipants 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).
Phase 1b Cohort 2: Bemcentinib 100 mg	Experimental	Drug: Bemcentinib, Drug: Pembrolizumab, Drug: Pemetrexed, Drug: CarboplatinParticipants 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).
Phase 1b Cohort 3: Bemcentinib 150 mg	Experimental	Drug: Bemcentinib, Drug: Pembrolizumab, Drug: Pemetrexed, Drug: CarboplatinParticipants 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).
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)	Experimental	Drug: Bemcentinib, Drug: Pembrolizumab, Drug: Pemetrexed, Drug: CarboplatinParticipants 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BemcentinibBemcentinib capsules will be administered daily orally.	Drug	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)
PembrolizumabPembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.	Drug	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)
PemetrexedPemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.	Drug	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)
CarboplatinCarboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.	Drug	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)

Primary outcome

Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Cycle 1 (the first 21 days of treatment)
DLT graded using NCI CTCAE Version 5.0 based on the Investigator assessment.
Phase 2a: Objective Response Rate (ORR) at 6 Months
Time frame: 6 months
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Phase 2a: Objective Response Rate (ORR) at 12 Months
Time frame: 12 months
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.

Results and safety

Results posted to the registry on 29 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1b Cohort 1: Bemcentinib 75 mg	3	0
Phase 1b Cohort 2: Bemcentinib 100 mg	3	0
Phase 1b Cohort 3: Bemcentinib 150 mg	4	0
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)	16	0

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

Time frame: Cycle 1 (the first 21 days of treatment). Count of participants. Unit: Participants

Measure	Phase 1b Cohort 1: Bemcentinib 75 mg n = 3	Phase 1b Cohort 2: Bemcentinib 100 mg n = 3	Phase 1b Cohort 3: Bemcentinib 150 mg n = 4
Value	0	0	0

Population analysed: This analysis population included all 10 participants who were enrolled into Phase 1b of the study and completed at least one cycle of treatment for evaluation of DLT.

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

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b) n = 16
Value	0

Population analysed: This analysis population included all 16 participants who were enrolled into Phase 2a of the study and completed sufficient cycles of treatment up to the 6-month timepoint.

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

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b) n = 16
Value	0

Population analysed: This analysis population included all 16 participants who were enrolled into Phase 2a of the study and completed sufficient cycles of treatment up to the 12-month timepoint.

Adverse events

Time frame: Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1b Cohort 1: Bemcentinib 75 mg	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Phase 1b Cohort 2: Bemcentinib 100 mg	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Phase 1b Cohort 3: Bemcentinib 150 mg	1 of 4 (25%)	4 of 4 (100%)	3 of 4
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)	6 of 16 (37.5%)	15 of 16 (93.8%)	6 of 16

Limitations and caveats (from the sponsor): The study was terminated early due to lack of efficacy, therefore the study enrolled a smaller than planned number of participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

34 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bemcentinib, Pembrolizumab and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by BerGenBio ASA at 34 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Spain, United States, France, Greece, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) (time frame: Cycle 1 (the first 21 days of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05469178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.