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

NCT07803848 | Recruiting Phase 2 DMC

• 3 other identifiers: AIO-TRK-06242025-522437-65-002025
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Small-cell Lung Cancer

Keywords

poor performance status; ECOG 2; tarlatamab

Outcome Measures

Primary Outcomes (1)

• Overall Survival Rate at 12 Months

  Percentage of participants who are alive 12 months after initiation of study treatment.

  12 months

Secondary Outcomes (9)

• Overall Survival (OS)

  From initiation of study treatment until death from any cause, assessed up to 48 months

• Progression-Free Survival (PFS)

  From initiation of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months

• Objective Response Rate (ORR)

  From initiation of study treatment until documented disease progression, assessed up to 48 months

• Intracranial Objective Response Rate (iORR)

  From initiation of study treatment until documented intracranial disease progression, assessed up to 48 months

• Rate of Participants Tolerating Tarlatamab Until First Disease Assessment

  From first dose until first scheduled disease assessment after 2 months

Study Arms (1)

Tarlatamab

EXPERIMENTAL

Participants receive tarlatamab intravenously at a step dose of 1 mg on Cycle 1 Day 1, followed by the target dose of 10 mg on Cycle 1 Day 8 and Cycle 1 Day 15, and every two weeks thereafter.

Drug: Tarlatamab

Interventions

Tarlatamab DRUG

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.

Tarlatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Bone marrow insufficiency:
• neutrophil count \< 1.5/nl or
• hemoglobin \<8 mg/dl or
• platelets \<100/nl
• Advanced liver disease:
• Subjects with pre-existing chronic liver disease:
• iii. Total bilirubin \> 1.5xULN or iv. ALT or AST \> 3xULN
• Subjects with no relevant prior chronic liver disease and elevated liver parameters due to liver metastases:
• v. Total bilirubin \> 3xULN or vi. ALT or AST \> 10xULN c. International normalized ratio (INR) \> 2.0 and partial thromboplastin time (PTT) or activated partial thromboplastin time (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
• Advanced kidney disease:
• CKD-EPI GFR \<20 ml/min/1.73m²
• Heart failure with reduced ejection fraction (EF \< 40%, assessed by echochardiography performed within 3 months prior to C1D1)

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead

Study Sites (8)

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

Malteser Krankenhaus St. Franziskus-Hospital

Flensburg, 24939, Germany

RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

RECRUITING

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

RECRUITING

Klinikum der Universität München

München, 80336, Germany

RECRUITING

Klinikum Stuttgart

Stuttgart, 70174, Germany

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Marcel Wiesweg, MD

CONTACT

+49 30 8145344; marcel.wiesweg@uk-essen.de

Tim Overkamp, PhD

CONTACT

+49 30 8145344; SPACE-T@aio-studien-ggmbh.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. Participants and investigators know that all participants receive tarlatamab.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants are assigned to a single treatment group and receive tarlatamab. There is no comparator or control group.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 4, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)