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Clinical Trials in the EU / 2025-522162-75-00
Authorised, recruiting Phase II

A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer

2025-522162-75-00 · tracked via the Priya Life Science EU tracker
Sponsor
Academisch Ziekenhuis Maastricht
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Respiratory Tract Diseases
Decision date
15/04/2026
Enrollment target
35
Sites
Netherlands

Condition studied

patients with asymptomatic active brain metastases from small cell lung cancer

Investigational medicinal product(s)

Tarlatamab

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

- BM ORR (RANO-BM). This will be evaluated with MRI brain after six weeks of treatment and there-after every six weeks. Confirmed BM ORR according to RANO-BM will be measured at 12 weeks.

Endpoint detail

All imaging related endpoints will be measured with MRI brain for BM related outcomes and CT chest and upper abdomen for extracranial related outcomes after six weeks of treatment and thereafter eve-ry six weeks. - Key secondary: BM DCR (RANO-BM), CNS PFS (RANO-BM) - Extracranial ORR and DCR (RECIST 1.1) - extracranial PFS (based on RECIST 1.1) - overall PFS (based on RANO-BM for BM and RECIST 1.1 for extracranial lesions) - OS - Safety according to CTCAE v 5.0 during every visit

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522162-75-00 on CTIS ↗ ← All trials in the EU