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Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

A Phase II Multi Center Study of BGB324 in Combination With Pembrolizumab in Patients With Previously Treated Advanced Adenocarcinoma of the Lung

NCT03184571•BerGenBio ASA

View on ClinicalTrials.gov

Summary

This is an open-label, multi-center, single arm, phase II study to assess the anti-tumor activity and safety of bemcentinib in combination with pembrolizumab in up to 106 participants with previously treated, advanced adenocarcinoma of the lung. The study will enrol three cohorts of participants with previously treated, advanced adenocarcinoma of the lung. Cohort A will consist of participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy. Cohort B will consist of participants who received a maximum of one prior line of an anti-programmed death receptor (PD)-(L)1 therapy (monotherapy). Cohort C will consist of participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy. The primary objective is to assess the anti-tumor activity of bemcentinib in combination with pembrolizumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed informed consent.
•2. Male and non-pregnant females who were aged 18 years or older at the time of provision of informed consent.
•3. Histopathologically or cytologically documented Stage IV adenocarcinoma NSCLC; Note: Patients with a mixed cell histology including a significant area of adenocarcinoma histology were eligible.
•4. Cohort A: Had disease progression on or after a prior platinum-containing chemotherapy; Note: Patients with EGFR mutations or ALK genomic rearrangements had to have documented disease progression on at least 1 licensed therapy for these indications and may not have received platinum-containing chemotherapy.
•Cohort B:
•1. Had received a maximum of 1 prior line of an anti-PD-(L)1 therapy (monotherapy).
•2. Must have had disease control containing at least 2 doses of anti-PD-(L)1 therapy. Disease control was defined as:
•i. Stable disease for at least 12 weeks (date of first progression on anti-PD-(L)1 therapy) Or ii. Confirmed PR or CR - confirmatory scan must have been performed \>4 weeks from initial scan) c) Had disease progression when entering Screening (first date of progression of disease was taken as end date of response to previous anti-PD-(L)1 therapy) and this must have been within 12 weeks of last dose of treatment containing an anti-PD-(L)1 therapy. Progression should have been confirmed in 1 of the following ways: i. Having had 2 scan assessments completed at least 4 weeks apart, both showing progression according to response evaluation criteria in solid tumors (RECIST) 1.113 or ii. Having had 1 scan assessment completed showing disease progression according to standards used for previous therapy combined with rapid disease progression / clinical progression.
•Cohort C:
•1. Had received a maximum of 1 prior line of an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
+20 more criteria

Exclusion Criteria

•1. Had disease suitable for local therapy administered with curative intent.
•2. Had received more than 1 prior line of chemotherapy for advanced or metastatic adenocarcinoma of the lung. For all cohorts: Note: Patients may have received additional prior radiotherapy or chemotherapy in the adjuvant setting, providing it was completed at least 6 months prior to start of study treatment.
•3. Cohort A: Had received prior therapy with an immunomodulatory agent; Cohort B: Had received prior chemotherapy alone or in combination with immunotherapy in the metastatic setting.
•4. Had a known additional malignancy that was progressing or required active treatment; Note: Exceptions included basal cell carcinoma of the skin, squamous cell carcinoma of the skin that had undergone potentially curative therapy, or in situ cervical cancer.
•5. Had known active central nervous system (CNS) metastases and/or carcinomatous meningitis; Note: Patients with previously treated brain metastases could participate provided they were stable (without evidence of progression by scans \[using the identical modality for each assessment, either MRI or CT scan\] for at least 4 weeks prior to the first dose of study treatment and any neurological symptoms had returned to Baseline), having no evidence of new or enlarging brain metastases, and were not using steroids for at least 7 days prior to study treatment.
•6. History of the following cardiac conditions:
•1. Congestive cardiac failure of \> Grade II severity according to the New York Heart Association (defined as symptomatic at less than ordinary levels of activity).
•2. Ischemic cardiac event including, myocardial infarction, within 3 months before the first dose.
•3. Uncontrolled cardiac disease, including unstable angina, uncontrolled hypertension (ie, sustained systolic blood pressure (BP) \>160 mm Hg or diastolic BP \>90 mm Hg), or need to change medication because of lack of disease control within 6 weeks before the provision of consent.
•4. History or presence of sustained bradycardia (≤55 beats per minute), left bundle branch block, cardiac pacemaker, or ventricular arrhythmia; Note: Patients with a supraventricular arrhythmia requiring medical treatment but with a normal ventricular rate were eligible.
+32 more criteria

Locations (13)

Dartmouth-Hitchcock Medical Center (DHMC)

Lebanon, New Hampshire, United States

Medical College of Wisconsin, 9200 W Wisconsin Avenue

Milwaukee, Wisconsin, United States

Radiumhospitalet, Oslo University Hospital PB

Oslo, Norway

Hospital Universitari Germans Trias i Pujol-ICO

Barcelona, Badalona, Spain

Hospital Teresa Herrera

A Coruña, Spain

Servicio de Oncologia Hospital del Mar

Barcelona, Spain

Hospital Universitario Vall d'Hebron (VHIR)

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Universitario Fundacion Jimene Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre, Servicio de oncologia

Madrid, Spain

Key Dates

Start Date

October 2, 2017

Primary Completion Date

October 27, 2022

Completion Date

October 27, 2022

Last Updated

September 25, 2025

Enrollment

ACTUAL participants

Conditions

Lung Cancer MetastaticNSCLC Stage IVAdenocarcinoma of Lung

Interventions

Pembrolizumab

DRUG

Bemcentinib

DRUG

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

NCT06219317

NSCLC Stage IV

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

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