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
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Main Inclusion Criteria:
- Histologically-confirmed or cytologically confirmed diagnosis of advanced (Stage IIIb/IIIc) or metastatic (Stage IV) (AJCC Edition 8) non-squamous NSCLC not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (Phase 1b) targetable with first-line treatment.
- Histologically-confirmed or cytologically confirmed diagnosis of stage of advanced (Stage IIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11 mutation, not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (phase 2a) targetable with first-line treatment.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC
- Have measurable disease per RECIST 1.1 as assessed by the investigator
EXCLUSION CRITERIA
Main Exclusion Criteria:
- Has received any prior chemotherapy or biological therapy for locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) adenocarcinoma of the lung
- Received radiation therapy within 2 weeks prior to starting study treatment or has not recovered (i.e. <=Grade 1 at baseline) from AEs due to a previous radiation therapy
- Major surgery within 28 days prior to start of study treatment and failure to have recovered adequately from the complications of the surgery/intervention prior to the first dose of study treatment
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Carcinoma, Non-Small-Cell Lung
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
64
Est. Completion Date
Jul 17, 2029
Treatment Type
INTERVENTIONAL
Sponsor
BerGenBio ASA
ClinicalTrials.gov NCT Identifier
NCT05469178
Study Number
BGBC016
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