drugset / Trial / NCT07242547

Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients

NCT07242547

Phase 2 Recruiting 37 enrolled Fundación GECP
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, phase II, exploratory and multi-centre clinical trial. 37 Limited stage SCLC patients not eligible for concurrent chemo-radiotherapy will be enroll. Patients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will be treated with maintenance Tarlatamab. Patients will receive maintenance with Tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death. The primary objective is to evaluate the Progression free survival (PFS). Patient accrual is expected to be completed within 2 years. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 2 years after enrollment. The study will end once survival follow-up has concluded.

Timeline

Start
2026-05-20
Primary completion
2030-06-01
Completion
2030-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tarlatamab Protein / enzyme biologic Intravenous