Asrar Alahmadi
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 that 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, 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 tumor cell ability to grow and spread. This may increase the time to progression (growing, spreading, or worsening) and help patients with extensive-stage SCLC live longer.
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 the 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 for 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 Therap…
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…
Undergo biopsies
Undergo blood sample collection
Undergo computed tomography
Undergo ECHO
Ancillary studies
Undergo MRI
Undergo MUGA
Ancillary studies
Given IV
Arctuva estimate
Verify or correct the compensation shown for this listing.