About this trial
This phase II trial tests the effect of tarlatamab in treating patients with small cell lung cancer (SCLC) that has spread from where it first started to other parts of the body (extensive-stage). SCLC is an aggressive cancer which has a low 5-year survival rate. Tarlatamab is a bispecific antibody that can bind to two different antigens at the same time. Tarlatamab binds to DLL3 which is a protein found on the surface of some types of tumor cells, including small-cell lung cancer, and to CD3 which is present on immune system T-cells (a type of white blood cell) and may interfere with the ability of tumor cells to grow and spread. This may increase the length of time to progression (growing, spreading, or getting worse) and help patients with extensive-stage SCLC live longer.
Eligibility criteria
Qualifiers
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Age ≥ 18 years at the time of consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2
Disqualifiers
Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment
Patients with a prior or concurrent malignancy whose natural history or treatment could potentially interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial
Symptomatic brain metastases and/or leptomeningeal disease
Clinically significant cardiovascular disease per the investigator. Examples include unstable arrhythmia, unstable angina, myocardial infarction, and/or symptomatic congestive heart failure (New York Heart Association class II) within 3 months of the first dose of tarlatamab
Trial design
Treatments tested in this trial
- Biopsy Procedure
- Biospecimen Collection
- Computed Tomography
- Echocardiography Test
- Electronic Health Record Review
- Magnetic Resonance Imaging
- Multigated Acquisition Scan
- Questionnaire Administration
- Tarlatamab
Treatment groups
Locations
1Sponsors and collaborators
Asrar Alahmadi
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Amgen
Collaborator