Tarlatamab for SCLC Brain Metastases

NCT07402343 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: T-BRAIN2025-522162-75-00
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Small Cell Lung Cancer; Brain Metastases, Adult

Outcome Measures

Primary Outcomes (1)

• Intracranial overall response rate (ORR)

  Brain metastases ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on central and local investigator's assessment according to RANO-BM criteria on brain MRI

  Up to 36 months

Secondary Outcomes (8)

• Brain metastases (BM) disease control rate (DCR)

  Up to 36 months

• Median CNS PFS

  Up to 36 months

• Extracranial ORR

  Up to 36 months

• Extracranial DCR

  Up to 36 months

• Extracranial PFS

  Up to 36 months

Other Outcomes (5)

• Efficacy of tarlatamab (survival) in relation to previous cranial radiotherapy

  Up to 36 months

• Safety of tarlatamab (adverse events) in relation to previous cranial radiotherapy

  Up to 36 months

• Efficacy of tarlatamab in relation to concomitant steroid use

  Up to 36 months

Study Arms (1)

Tarlatamab

EXPERIMENTAL

Tarlatamab intravenous: 1 mg on day 1, followed by 10 mg on days 8 and 15 of cycle 1; thereafter every 2 weeks in cycles of 28 days

Drug: Tarlatamab

Interventions

Tarlatamab DRUG

Cycle 1: 1 mg on day 1, followed by 10 mg on days 8 and 15 Cycles thereafter: 10 mg every two weeks, in cycles of 28 days Treatment continues till unacceptable toxicity or disease progression

Tarlatamab

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following 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).
• "Untreated" refers to the lesion not being previously treated with stereotactic radiosurgery/therapy (SRS/SRT) or surgery.
• Prior treatment with whole brain radiation therapy or local surgery is permissible provided unequivocal progression in the lesion has since occurred
• For at least 7 days prior to study start: Patient must be asymptomatic from CNS metastases and on a stable dose of anti-epileptics and corticosteroids. Maximum dose of steroids is 10 mg prednisolone or equivalent/day, dose should be noted.
• Adequate organ and bone marrow function, defined as:
• a. Hematological function: i. Absolute neutrophil count ≥1.5 x109/L ii. Platelet count ≥ 100 x109/L iii. Hemoglobin ≥ 5.6 mmol/l b. Coagulation function: i. Protrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to start of study treatment.
• c. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Dietin Renal Disease (MDRD) calculation \> 30 mL/min/1.73 m2 d. Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3x ULN (or \< 5x ULN for subjects with liver metastases) ii. Total bilirubin \< 1.5x ULN (or \< 2x ULN for subjects with liver metastases), except for subjects with Gilberts disease e. Pulmonary function: i. No clinically significant pleural effusion. Pleural effusions managed with indwelling pleural catheter (eg, PleurX) are allowed.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• adequately treated cervical cancer in situ without evidence of disease
• adequately treated breast ductal carcinoma in situ without evidence of disease
• prostatic intraepithelial neoplasia without evidence of prostate cancer
• adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g. colitis or Crohn's disease\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis. The following are exceptions to this criterion:

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• The Netherlands Cancer Institute: collaborator
• Erasmus Medical Center: collaborator
• University Medical Center Groningen: collaborator

Study Sites (4)

The Netherlands Cancer Institute

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Lizza Hendriks, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)