The primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
Tarlatamab will be administered by IV infusion.
Proportion of participants with confirmed objective response to Tarlatamab
Time frame: Approximately 52 Months
Proportion of participants with complete response to Tarlatamab
Time frame: Approximately 52 Months
Proportion of participants with partial response to Tarlatamab
Time frame: Approximately 52 Months
Average serum concentrations of Tarlatamab
Time frame: Approximately 52 Weeks
Duration of confirmed response, defined as the time from the first documentation of OR until the first documentation of disease progression or death
Time frame: Approximately 52 Months
Disease control, defined as objective response or stable disease
Time frame: Approximately 52 Months
Duration of disease control
Time frame: Approximately 52 Months
Progression-free survival, defined as the time from randomization to the first documentation of disease progression or death due to any cause
Time frame: Approximately 52 Months
Objective response, defined as best overall response of CR or PR
Time frame: Approximately 52 Months
Overall survival, defined as the time from randomization to death due to any cause
Time frame: Approximately 52 Months
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University of California Los Angeles
Los Angeles, California, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Plainville, Connecticut, United States
AdventHealth Hematology and Oncology
Orlando, Florida, United States
City of Hope Chicago
Rockford, Illinois, United States
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
New York Oncology Hematology PC
Albany, New York, United States
Duke University
Durham, North Carolina, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, United States
Guthrie Medical Group
Sayre, Pennsylvania, United States
Tennessee Oncology PLLC - Chattanooga
Chattanooga, Tennessee, United States
...and 68 more locations
Overall Survival rate at 6 months and 1 year from randomization
Time frame: Approximately 52 Months
Number of participants with treatment-emergent adverse events
Time frame: Approximately 52 Months
Number of participants with anti-tarlatamab antibody formation
Time frame: Approximately 52 Months