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Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients
Sponsor: Fundación GECP
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.
Official title: A Phase II Clinical Trial of Tarlatamab as Maintenance Treatment After Sequential Chemo-radiotherapy for Limited Stage SCLC Patients Not Eligible for Concurrent Chemo-radiotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2026-02-28
Completion Date
2030-06-01
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Tarlatamab
Patients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will receive tarlatamab maintenance treatment. Patients will receive maintenance with tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death. Patients who still benefit from the drug treatment at the end of the study or at early termination of the clinical trial, will continue receiving the drug until progression disease.
Locations (20)
Hospital General Universitario de Albacete
Albacete, Albacete, Spain
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Alicante, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain
Fundació Althaia
Manresa, Barcelona, Spain
Hospital de Basurto
Bilbao, Bizkaia, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Madrid, Spain
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, Spain
Hospital Regional de Málaga
Málaga, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Santa Maria Mai - Complexo Hospitalario Universitario Ourense
Ourense, Ourense, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain