RecruitingPhase 2NCT07803848

Study to Confirm Efficacy and Feasibility of Tarlatamab Treatment in Patients With Extensive Stage Small-cell Lung Cancer With Poor Performance Status

A Single-arm Phase II-study to Confirm Efficacy and Feasibility of Tarlatamab Treatment in Patients With Extensive Stage Small-cell Lung Cancer With Poor Performance Status


Sponsor

AIO-Studien-gGmbH

Enrollment

57 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The SPACE-T study is a clinical trial for people with advanced small-cell lung cancer (SCLC) whose cancer has returned or spread despite previous treatment and whose general health is reduced (ECOG performance status 2). The study will include 57 participants at about 15 sites in Germany. The study is testing tarlatamab, a treatment that helps the immune system recognize and attack cancer cells. Participants will receive tarlatamab through a vein, starting with a lower dose of 1 mg, followed by doses of 10 mg. Treatment will then generally be given every two weeks. The main purpose of the study is to find out how effective tarlatamab is in this group of patients by assessing how many participants are alive 12 months after starting the study. The study will also examine how well the treatment controls the cancer, including cancer that has spread to the brain, how well participants tolerate the treatment, its side effects, and its impact on quality of life. Patients with poorer general health are often not included in clinical trials, even though they represent an important part of the people treated for SCLC in everyday clinical practice. The SPACE-T study aims to provide more information about whether tarlatamab is effective and feasible for these patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Tarlatamab for people with small cell lung cancer. The study is currently recruiting participants at 8 locations.

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

Tarlatamab is administered intravenously at a step dose of 1 mg on Cycle 1 Day 1, followed by a target dose of 10 mg on Cycle 1 Day 8 and Cycle 1 Day 15, and every two weeks thereafter.


Locations(8)

Evangelische Lungenklinik Berlin

Berlin, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Universitätsklinikum Essen

Essen, Germany

Malteser Krankenhaus St. Franziskus-Hospital

Flensburg, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Johannes Wesling Klinikum Minden

Minden, Germany

Klinikum der Universität München

München, Germany

Klinikum Stuttgart

Stuttgart, Germany

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NCT07803848


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