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
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)
• Recurrent or metastatic disease. In case of local-only recurrence, availability of local treatment options must have been excluded
• Has received at least one prior line of treatment in the recurrent or metastatic setting
• Has received a prior treatment line with platinum, etoposide, and a PD-L1 antibody. Treatment with chemotherapy only is acceptable if the patient had a contraindication for CPI treatment
• Measurable disease according to RECIST v1.1