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.
Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
Participants who progressed or recurred following 1 platinum-based regimen.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.
History of other malignancy within the past 2 years, with exceptions defined in the protocol.
Parallel
Tarlatamab
DrugAdministered via SC injection or IV infusion
Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
Predose Concentration (Ctrough) of Tarlatamab
Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Progression free survival (PFS) per RECIST v1.1
Duration of response (DOR) per RECIST v1.1
Disease control (DC) per RECIST v1.1
