A Phase 1 interventional study of Tarlatamab in Extensive Stage Small Cell Lung Cancer, sponsored by Amgen. Recruiting at 31 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Amgen · Phase 1, Interventional, and Basic science
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's planned enrollment of 220 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.
Exclusion Criteria:
Tarlatamab will be administered as a SC injection in Part 1.
Drug: Tarlatamab
Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.
Drug: Tarlatamab
Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.
Drug: Tarlatamab
Administered by SC injection.
Also known as: AMG 757, Imdelltra
Number of Participants with Dose-limiting toxicities (DLTs)
Time frame: Up to day 21
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 24 months
Number of Participants with Changes in Vital Signs
Time frame: Up to approximately 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Up to approximately 24 months
Maximum Serum Concentration (Cmax) of Tarlatamab
Time frame: Up to approximately 12 months
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
Time frame: Up to approximately 12 months
Time to Cmax (Tmax) of Tarlatamab
Time frame: Up to approximately 12 months
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Time frame: Up to approximately 12 months
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to approximately 24 months
Duration of Response (DOR) per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Response (TTR) per RECIST 1.1
Time frame: Up to approximately 24 months
Progression-free Survival (PFS) per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Progression per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Subsequent Therapy
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation
Time frame: Up to approximately 24 months
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
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