OncoMatch/Clinical Trials/NCT07803848
Study to Confirm Efficacy and Feasibility of Tarlatamab Treatment in Patients With Extensive Stage Small-cell Lung Cancer With Poor Performance Status
Is NCT07803848 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Tarlatamab for small-cell lung cancer.
Treatment: Tarlatamab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Recurrent or metastatic disease. In case of local-only recurrence, availability of local treatment options must have been excluded
Performance status
ECOG 2–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — recurrent or metastatic setting
Has received at least one prior line of treatment in the recurrent or metastatic setting
Must have received: platinum-based chemotherapy (platinum)
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
Must have received: etoposide (etoposide)
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
Must have received: anti-PD-L1 therapy
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
Cannot have received: DLL3-directed treatment
Prior DLL3-directed treatment
Lab requirements
Blood counts
neutrophil count < 1.5/nl or hemoglobin <8 mg/dl or platelets <100/nl
Kidney function
CKD-EPI GFR <20 ml/min/1.73m²
Liver function
Subjects with pre-existing chronic liver disease: Total bilirubin > 1.5xULN or ALT or AST > 3xULN. Subjects with no relevant prior chronic liver disease and elevated liver parameters due to liver metastases: Total bilirubin > 3xULN or ALT or AST > 10xULN. INR > 2.0 and PTT or aPTT ≥ 1.5 x ULN, except for subjects undergoing new class anticoagulant therapy (eg, Apixaban, Rivaroxaban, Edoxaban) with stable dose for 2 weeks prior to enrollment
Cardiac function
Heart failure with reduced ejection fraction (EF < 40%, assessed by echochardiography performed within 3 months prior to C1D1); Hemodynamically significant pericardial effusion
Bone marrow insufficiency: neutrophil count < 1.5/nl or hemoglobin <8 mg/dl or platelets <100/nl; Advanced liver disease: ...; Advanced kidney disease: CKD-EPI GFR <20 ml/min/1.73m²; Heart failure with reduced ejection fraction (EF < 40%); Hemodynamically significant pericardial effusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07803848 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior DLL3-directed treatment disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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