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

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
BerGenBio ASA
Study ID
NCT05469178
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 3, 2023
Status verified
Oct 2025
Primary completion
Apr 3, 2025
Completion
Apr 3, 2025

Study Design

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

Arms

  • Experimental: Phase 1b Cohort 1: Bemcentinib 75 mg
    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).
  • Experimental: Phase 1b Cohort 2: Bemcentinib 100 mg
    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).
  • Experimental: Phase 1b Cohort 3: Bemcentinib 150 mg
    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).
  • Experimental: Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)
    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).

Primary Outcome Measure

Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 (the first 21 days of treatment) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
University of ChicagoChicagoIllinois60637-
Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of MarylandBaltimoreMaryland21201-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Duke University Medical Center - Duke Cancer CenterDurhamNorth Carolina27710-
Tennessee Oncology PLLCNashvilleTennessee37203-
UT Southwestern Medical CenterDallasTexas75390-

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By research site
Mount Sinai Comprehensive Cancer Center· Miami Beach, FLUniversity of Chicago· Chicago, ILMarlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland· Baltimore, MDIcahn School of Medicine at Mount Sinai· New York, NYDuke University Medical Center - Duke Cancer Center· Durham, NCTennessee Oncology PLLC· Nashville, TN

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