The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Administered via SC injection or IV infusion
University of Florida Health Cancer Center at Orlando Health
Orlando, Florida, United States
RECRUITINGCancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
RECRUITINGArea Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
Time frame: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
Predose Concentration (Ctrough) of Tarlatamab
Time frame: On Cycle 2 Day 15 (each cycle is 28 days)
Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Time frame: Up to approximately 4 years
Progression free survival (PFS) per RECIST v1.1
Time frame: Up to approximately 4 years
Duration of response (DOR) per RECIST v1.1
Time frame: Up to approximately 4 years
Disease control (DC) per RECIST v1.1
Time frame: Up to approximately 4 years
Overall survival (OS)
Time frame: Up to approximately 4 years
Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)
Time frame: Up to approximately 4 years
Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)
Time frame: Up to approximately 4 years
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
Time frame: Up to approximately 4 years
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Oncology Hematology West PC
Omaha, Nebraska, United States
RECRUITINGLyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
RECRUITINGBeijing Chaoyang Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, China
RECRUITINGTokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, Japan
RECRUITINGUniversitaetsspital Zuerich
Zurich, Switzerland
RECRUITINGResponses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother
Time frame: Up to approximately 4 years
Responses to Therapy Administration Satisfaction Questionnaire (TASQ)
Time frame: Up to approximately 4 years
Number of Participants with Anti-tarlatamab Antibody Formation
Time frame: Up to approximately 4 years