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.
Written informed consent obtained from the subject prior to performing any protocol-related procedures.
Age ≥ 18 years
ECOG performance status 2
Histologically confirmed small-cell lung cancer (initial mixed histology / combined SCLC permitted if re-biopsy of current progression shows SCLC)
ECOG performance status 0, 1, 3 or 4
Life expectancy less than three months
Active brain metastases with unstable symptoms (new or progressive neurological symptoms within the last 3 weeks)
neutrophil count < 1.5/nl or
Single group
Tarlatamab
DrugTarlatamab 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.
Overall Survival Rate at 12 Months
Percentage of participants who are alive 12 months after initiation of study treatment.
Overall Survival (OS)
Time from initiation of study treatment to death from any cause.
Progression-Free Survival (PFS)
(PFS) Time from initiation of study treatment to disease progression or death from any cause, whichever occurs first.
Objective Response Rate (ORR)
Percentage of participants with an objective tumor response according to RECIST v1.1.
Intracranial Objective Response Rate (iORR)
Percentage of participants with brain metastases who achieve an objective intracranial tumor response.
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