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

Part of paid clinical trials in La Jolla, California.

Sponsor
BerGenBio ASA
Study ID
NCT02424617
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Participants received erlotinib 150 mg for the 21-day cycle.
  • Bemcentinib — DRUG
    Participants received bemcentinib 600 mg on Days 1 and 2 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle.
  • Bemcentinib — DRUG
    Participants received starting loading dose of bemcentinib 600 mg (200 mg on Days 1, 2 and 3) and bemcentinib 100 mg as daily maintenance dose for the 21-day cycle. Depending on tolerability and DLT, the loading dose of bemcentinib was escalated to 800mg (400 mg on Days 1 and 2) and bemcentinib 100 mg as daily maintenance for the 21- day cycle and to 1200 mg daily (600 mg on Days 1 and 2, or 400 mg on Days 1, 2 and 3) and bemcentinib 200 mg as daily maintenance for the 21- day cycle).
  • Bemcentinib — DRUG
    Participants received bemcentinib 400 mg on Days 1, 2 and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle.

Study Details

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 Dates

First listed
Apr 23, 2015
Start date
Apr 19, 2015
Status verified
Feb 2025
Primary completion
Aug 25, 2021
Completion
Aug 25, 2021

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1- Run in Arm (Bemcentinib Monotherapy)
    Participants in this arm received bemcentinib as monotherapy. This was to determine the safety and tolerability of bemcentinib when administered alone.
  • Experimental: Phase 1- Arm A (Bemcentinib + Erlotinib)
    Participants in this arm received erlotinib with bemcentinib. A standard 3+3 design to determine the dose of bemcentinib that could be safely administered in combination with erlotinib in participants who had received prior treatment with erlotinib. This was to determine the maximum tolerated dose of bemcentinib that could be safely administered with erlotinib.
  • Experimental: Phase 2- Arm B (Bemcentinib + Erlotinib)
    Participants in this arm received erlotinib with bemcentinib in participants with an activating epidermal growth factor receptor (EGFR) mutation who are T790M negative and who had progressed after receiving treatment with an approved EGFR tyrosine kinase inhibitor (TKI) \[osimertinib, afatinib, or gefitinib\].
  • Experimental: Phase 2- Arm C (Bemcentinib + Erlotinib)
    Participants in this arm received erlotinib daily along with bemcentinib in participants with an activating EGFR mutation (including exon 19 deletion or exon 21 \[L858R\] substitution or other rearrangement of the EGFR gene mutation) who had received greater than or equal to (≥) 12 weeks of erlotinib without disease progression.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAE) [ Time Frame: First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days) ]

Locations (10)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-0698-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Moffitt Cancer CenterTampaFlorida33612-
Horizon Oncology Research,LafayetteIndiana47905-
Henry Ford Health SystemDetroitMichigan48202-
The Sarah Cannon Research Institute Tennessee Oncology PLLCNashvilleTennessee37203-
Mary Crowley Cancer Research CentersDallasTexas75230-
Southwestern Medical CenterDallasTexas75390-8852-
MD Anderson Cancer CenterHoustonTexas77030-
Oncology Consultants PAHoustonTexas77030-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UC San Diego Moores Cancer Center· La Jolla, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAMoffitt Cancer Center· Tampa, FLHorizon Oncology Research· Lafayette, INHenry Ford Health System· Detroit, MIThe Sarah Cannon Research Institute Tennessee Oncology PLLC· Nashville, TN

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