A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer
Asrar Alahmadi
Summary
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.
Description
PRIMARY OBJECTIVES: I. To assess the 6-month progression-free survival (PFS) rate for extensive-stage SCLC (ES-SCLC) patients treated with tarlatamab as first-line therapy. II. Interim analysis for futility monitoring: To monitor rate of rapid disease progression (PD) at 4 weeks, with a goal of \< 40%. SECONDARY OBJECTIVES: I. To evaluate the safety and toxicity of tarlatamab as first-line therapy ES-SCLC using National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) version 5.0 for all adverse events (AEs) and the American Society for Transplantation and Cellular Therapy (ASTCT…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Have a histologically or cytologically documented new diagnosis of the extensive-stage (i.e., metastatic and/or recurrent) SCLC. Patients with multiple lung nodules and/or lymph node involvement that are too extensive or h…
Interventions
- ProcedureBiopsy Procedure
Undergo biopsies
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo computed tomography
- ProcedureEchocardiography Test
Undergo ECHO
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureMultigated Acquisition Scan
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio