The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
563
Intravenous (IV) infusion
IV infusion
OS
Time frame: Up to approximately 3 years
Progression Free Survival (PFS)
Time frame: Up to approximately 3 years
Overall Response (OR)
Time frame: Up to approximately 3 years
Disease Control (DC) Rate
Time frame: Up to approximately 3 years
Duration of Response (DoR)
Time frame: Up to approximately 3 years
PFS at 6 Months
Time frame: 6 months
PFS at 1 Year
Time frame: 1 year
PFS at 2 Years
Time frame: 2 years
OS at 6 Months
Time frame: 6 months
OS at 1 Year
Time frame: 1 year
OS at 2 Years
Time frame: 2 years
OS at 3 Years
Time frame: 3 years
Time to Progression (TTP)
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Infirmary Cancer Center
Mobile, Alabama, United States
University of Southern California
Los Angeles, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University Cancer and Blood Center LLC
Athens, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
University of Illinois Chicago
Chicago, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
...and 209 more locations
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 9 months
Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: Up to approximately 3 years
Number of Participants with Serious TEAEs
Time frame: Up to approximately 3 years
Number of Participants with TEAEs Leading to Discontinuation of Treatment
Time frame: Up to approximately 3 years
Number of Participants with Fatal TEAEs
Time frame: Up to approximately 3 years
Number of Participants with Treatment-related Adverse Events (AEs)
Time frame: Up to approximately 9 months
Number of Participants with Adverse Events of Interest (EOI)
Time frame: Up to approximately 9 months
Serum Concentrations of Tarlatamab
Time frame: Day 1 up to approximately 6 months
Number of Participants with Antitarlatamab Antibody Formation
Time frame: Up to approximately 9 months
Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)
Time frame: Baseline to Week 13 and Week 25
Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13
Time frame: Baseline to Week 13 and Week 25
Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13
Time frame: Baseline to Week 13 and Week 25
Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13
Time frame: Baseline to Week 13 and Week 25
TTD for Global Health Status as Measured by EORTC-QLQ-C30
Time frame: Baseline to Week 13 and Week 25
TTD for Quality of Life as Measured by EORTC-QLQ-C30
Time frame: Baseline to Week 13 and Week 25