The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
REGN4659 will be administered by intravenous (IV) infusion.
Cemiplimab will be administered by intravenous (IV) infusion.
Regeneron Investigational Site
Chicago, Illinois, United States
Regeneron Investigational Site
Grand Rapids, Michigan, United States
Regeneron Investigational Site
Charlotte, North Carolina, United States
Regeneron Investigational Site
Oklahoma City, Oklahoma, United States
Rate of dose limiting toxicities (DLTs) during the dose escalation phase
Time frame: Up to week 126
Rate of treatment emergent adverse events (TEAEs)
Time frame: Up to week 126
Rate of immune-related adverse events (irAEs)
Time frame: Up to week 126
Rate of serious adverse events (SAEs)
Time frame: Up to week 126
Rate of deaths
Time frame: Up to week 126
Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
Time frame: Up to week 126
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during the dose expansion phase
Time frame: Up to week 126
REGN4659 and cemiplimab concentrations in serum over time
Time frame: Up to week 126
ORR based on RECIST 1.1 during the dose escalation phase
Time frame: Up to week 126
ORR based on immune-based therapy Response Evaluation Criteria (iRECIST)
Time frame: Up to week 126
Best overall response (BOR)
Time frame: Up to week 126
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Regeneron Investigational Site
Nashville, Tennessee, United States
Regeneron Investigational Site
San Antonio, Texas, United States
Duration of response (DOR)
Time frame: Up to week 126
Disease control rate
Time frame: Up to week 126
Progression-free-survival (PFS) based on RECIST 1.1
Time frame: Up to week 126
PFS based on iRECIST
Time frame: Up to week 126
Overall survival (OS)
Time frame: Up to week 126