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RecruitingPhase 2NCT07242547

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

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

Sponsor

Fundación GECP

Enrollment

37 participants

Start Date

Feb 28, 2026

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tarlatamab — an immunotherapy drug — as maintenance treatment (ongoing treatment to prevent cancer coming back) after chemotherapy with or without radiation, for people with limited-stage small cell lung cancer (LS-SCLC) — a fast-growing form of lung cancer that is still confined to the chest. **You may be eligible if...** - You are 18 or older with a new confirmed diagnosis of limited-stage small cell lung cancer - You have completed chemotherapy combined with radiation OR chemotherapy alone, and your cancer has not progressed - You have at least one measurable or evaluable tumor - You are in reasonably good health (ECOG score 0–2) - Your expected survival is at least 3 months - Side effects from your prior treatment have resolved to mild or manageable levels **You may NOT be eligible if...** - Your small cell lung cancer is a mixed type - Your cancer has progressed during or after chemotherapy - Your prior treatment side effects have not resolved adequately Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTarlatamab

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

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NCT07242547