A Study of BGB324 (Bemcentinib) in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

Completed · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

A Phase 1/2 multi-center open-label study of BGB324 (bemcentinib) as a single agent (Run-in Cohort) and in combination with erlotinib (Arms A, B, and C) in participants with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC). Bemcentinib is a potent selective small molecule inhibitor of AXL, a surface membrane protein kinase receptor which is connected with poor prognosis and acquired resistance to therapy.

Key facts

Study ID

NCT02424617

Run by

BerGenBio ASA

People needed

40

Starts

2015-04-19

Expected to finish

2021-08-25

Last updated by the study team

2025-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Pregnant or lactating.
• Abnormal left ventricular ejection fraction (less than the lower limit of normal for a participants of that age at the treating institution or <45%).
• Treatment with any of the following; histamine receptor 2 inhibitors, proton pump inhibitors or antacids within 3 days or 5 half-lives, whichever is longer. The Investigator may initiate rescue treatment with these medications during the study, providing they are taken in the evening.
• History of an ischemic cardiac event, including myocardial infarction, within 3 months of consent.
• Pulmonary hemorrhage or hemoptysis >2.5 mL blood within 6 weeks of consent unless cause has been addressed and is medically resolved.
• Congestive cardiac failure of >Class II severity according to the New York Heart Association (NYHA) defined as symptomatic at less than ordinary levels of activity.
• Unstable cardiac disease, including unstable angina or unstable hypertension, as defined by the need for change in medication for lack of disease control within 3 months of consent.
• History or presence of sustained bradycardia (≤ 60 bpm) or history of symptomatic bradycardia, left bundle branch block, cardiac pacemaker or significant atrial tachyarrhythmias, as defined by the need for treatment.
• tachyarrhythmias, as defined by the need for treatment.
• Current treatment with agents that may prolong QT interval and may cause Torsade de Points which cannot be discontinued at least 2 weeks prior to treatment.
• Known family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy.
• Previous history of ≥ Grade 3 drug-induced QTc prolongation.
• Screening 12-lead triplicate electrocardiogram (ECG) with an average measurable interval utilizing Fridericia's correction (QTcF) >450 ms.
• Inadequate liver function as demonstrated by:
• Serum bilirubin ≥ 1.5 times the upper limit of normal range (ULN); or
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 times the ULN (up to 5 times the ULN in the presence of liver metastases).
• Inability to tolerate oral medication.
• Impaired coagulation as evidenced by:
• International normalized ratio (INR) >1.5 times ULN (or equivalent); or
• Activated partial thromboplastin time (aPTT) >1.5 times ULN.
• Existing gastrointestinal disease affecting drug absorption, such as celiac disease or Crohn's disease.
• Previous bowel resection that may impair study drug absorption.
• Impaired renal function as demonstrated by creatinine clearance of ≤ 50 mL/min determined by Cockcroft Gault formula.
• Absolute neutrophil count <1.5 x 109/L, hemoglobin <9.0 g/dL, platelet count <100 x 109/L in the absence of blood product support.
• Any evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the participant to participate in the study or which could jeopardize compliance with the protocol.

Where it is running

• UC San Diego Moores Cancer Center — La Jolla, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Horizon Oncology Research, — Lafayette, Indiana, United States
• Henry Ford Health System — Detroit, Michigan, United States
• The Sarah Cannon Research Institute Tennessee Oncology PLLC — Nashville, Tennessee, United States
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States
• Southwestern Medical Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Oncology Consultants PA — Houston, Texas, United States

Full record on ClinicalTrials.gov

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