Study of AMG757 Tarlatamab Combined With Radiation Therapy for DLL3 Positive Tumors A Phase III Trial Evaluating Safety and Response in Various Solid Tumors Including Small Cell Lung Cancer

What this Trial Is About

Researchers are studying the safety and effects of combining tarlatamab, a bispecific T-cell engager, with standard radiation therapy RT in patients with tumors that often express DLL3, a protein found in certain cancers. This Phase III trial focuses on patients 18 years and older with relapsed or refractory solid tumors, including small cell lung cancer and other neuroendocrine or DLL3-positive tumors. The study aims to assess safety and response rates, especially in tumors with high DLL3 presence or positivity. Participants receive tarlatamab through a step-up dosing schedule starting with 1 mg on the first day, then 10 mg doses on days 8 and 15 of the first cycle, and continuing every two weeks thereafter. The study has several groups one receives tarlatamab with concurrent radiation to extracranial sites, another expands to cranial radiation if safety is confirmed, and a sequential radiation group receives radiation either just before or interspersed with tarlatamab with washout periods. If safety concerns arise, a group receiving tarlatamab alone without radiation will be enrolled. Throughout the study, participants undergo regular monitoring for side effects, disease progression, and treatment response using imaging criteria. Researchers track dose-limiting toxicities related to radiation and tarlatamab, along with overall and progression-free survival, and the duration of treatment response. The study lasts up to 24 months or until disease progression, with careful assessments of organ function and neurological safety to ensure participant well-being.

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors