This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Tarlatamab will be administered as an intravenous (IV) infusion.
Carboplatin will be administered as an intravenous (IV) infusion.
Etoposide will be administered as an intravenous (IV) infusion.
Number of Participants with a Dose Limiting Toxicity (DLT)
Time frame: 24 months
Number of Participants with Treatment-emergent Adverse Events (TEAE)
Time frame: 24 months
Number of Participants with Treatment-related Adverse Events
Time frame: 24 months
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: 24 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Time frame: 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: 24 months
6-month Progression-free Survival (PFS)
Time frame: 24 months
Objective Response (OR)
Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 24 months
Duration of Response (DOR)
Time frame: 24 months
Disease Control Rate(DCR)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
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Atezolizumab will be administered as an intravenous (IV) infusion.
Durvalumab will be administered as an intravenous (IV) infusion.
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Henry Ford Health System
Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Swedish Cancer Institute Medical Oncology
Seattle, Washington, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
...and 34 more locations
Serum Concentration of Tarlatamab
Time frame: 24 months