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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Bemcentinib capsules will be administered daily orally.
Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
University of Chicago
Chicago, Illinois, United States
Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland
Baltimore, Maryland, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, United States
Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
DLT graded using NCI CTCAE Version 5.0 based on the Investigator assessment.
Time frame: Cycle 1 (the first 21 days of treatment)
Phase 2a: Objective Response Rate (ORR) at 6 Months
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Time frame: 6 months
Phase 2a: Objective Response Rate (ORR) at 12 Months
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Time frame: 12 months
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Tennessee Oncology PLLC
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Hôpital prive du Confluent SAS, Departement d'oncologie
Nantes, France
Centre Antoine Lacassagne
Nice, France
Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie
Paris, France
...and 24 more locations