Not Yet RecruitingPhase 2

Tarlatamab for SCLC Brain Metastases

Netherlands35 participantsStarted 2026-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed and written informed consent
✓. Age 18 years or older
✓. Patients with pathology proven metastatic SCLC
✓. Pretreated with at least platinum-doublet chemotherapy with or without immunotherapy, no maximum of previous lines of systemic therapy
✓. WHO/ECOG PS 0-1
✓. Estimated life expectancy 12 weeks or more
✓. At least one asymptomatic active (newly diagnosed or unequivocally progressive) untreated brain metastasis ≥ 5mm:
✓. Subjects with largest measurable intracranial lesion ≥5 mm but \<10mm may be allowed to enroll upon agreement with investigator (for patients with target lesions of ≥ 5mm but \<10 mm, 1.5 mm slice thickness brain MRI is required).

Exclusion criteria

✕. Symptomatic BM (if asymptomatic with corticosteroids with a maximum dose of steroids of 10 mg prednisolone or equivalent/day, the patient is eligible). If in doubt, discussion with the sponsor is necessary
✕. Leptomeningeal metastases (evaluated with MRI brain)
✕. BM in eloquent area (to be discussed with neuro-oncologist)
✕. Contra-indication for MRI
✕. Prior history of severe or life-threatening events from any immune-mediated therapy
✕. Grade 2 or higher toxicity from previous systemic therapy, except for alopecia
✕. History of other malignancy within the past 2 years, with the following exceptions:
✕. Malignancy treated with curative intent before enrolment, with no known active disease and felt to be at low risk for recurrence by the treating physician, after discussion with the sponsor

What they're measuring

Intracranial overall response rate (ORR)

Timeframe: Up to 36 months

Trial details

NCT IDNCT07402343

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02

Contact for this trial

Lizza Hendriks, MD, PhD

+31(0)43-3875047 lizza.hendriks@mumc.nl

View on ClinicalTrials.gov More Small Cell Lung Cancer trials