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

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
BerGenBio ASA
Study ID
NCT03184571
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma of Lung
  • Lung Cancer Metastatic
  • NSCLC Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab is a PD-1 inhibitor
  • Bemcentinib — DRUG
    Bemcentinib is a selective Axl kinase inhibitor;

Study Details

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.

Key Dates

Start date
Oct 2, 2017
Status verified
Sep 2025
Primary completion
Oct 27, 2022
Completion
Oct 27, 2022

Study Design

Enrollment
99 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A Bemcentinib + pembrolizumab
    Cohort A bemcentinib (BGB324) in combination with pembrolizumab will be administered to participants with previously treated, advanced adenocarcinoma of the lung who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy.
  • Experimental: Cohort B Bemcentinib + pembrolizumab
    Cohort B bemcentinib (BGB324) in combination with pembrolizumab will be administered to participants with previously treated, advanced adenocarcinoma of the lung who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy).
  • Experimental: Cohort C Bemcentinib + pembrolizumab
    Cohort C bemcentinib (BGB324) in combination with pembrolizumab will be administered to participants with previously treated, advanced adenocarcinoma of the lung who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: The disease response is the best improvement or change in a participants cancer burden, as measured from baseline (screening) and then measured again at regular intervals over the whole period of the study, an average of 24 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical Center (DHMC)LebanonNew Hampshire03756-
Medical College of Wisconsin, 9200 W Wisconsin AvenueMilwaukeeWisconsin53226-3522-

Related coverage on Hipa.ai

Find similar trials in Lebanon, NH

By research site
Dartmouth-Hitchcock Medical Center (DHMC)· Lebanon, NHMedical College of Wisconsin, 9200 W Wisconsin Avenue· Milwaukee, WI

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