RecruitingPhase 2NCT06401824

Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases

A Single Arm Phase II Study Evaluating Intracranial Efficacy of Sacituzumab Govitecan (SG) With Bevacizumab in Patients With Active, Asymptomatic Brain Metastases From Non-small Cell Lung Cancer (NSCLC)


Sponsor

Maastricht University Medical Center

Enrollment

25 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate whether the combination of sacituzumab govitecan (SG) and bevacizumab will result in shrinkage of brain metastases from patients with non-squamous non-small cell lung cancer (NSCLC), with disease progression on chemotherapy and immunotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — sacituzumab govitecan (a targeted antibody-drug conjugate) and bevacizumab (which cuts off blood supply to tumors) — for people with non-small cell lung cancer (NSCLC) that has spread to the brain. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-squamous NSCLC that has spread to the brain - You have at least one untreated brain metastasis of at least 5mm in size - Your cancer has already progressed on standard treatments (immunotherapy and/or chemotherapy, or targeted therapy) - Your general health and organ function are within acceptable ranges **You may NOT be eligible if...** - Cancer has spread to the lining of the brain (leptomeningeal disease) - You have previously been treated with a TROP2-targeting drug or an anti-angiogenic drug (bevacizumab or similar) - You have significant heart problems, active infections, or severe lung disease - You have active hepatitis B or C, or HIV with detectable viral load - You are pregnant or breastfeeding - You have had a prior bone marrow or organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan-Hziy 180 MG plus bevacizumab

Sacituzumab govitecan 10mg/kg intravenous day 1 and day 8 of a 21-day cycle, + bevacizumab 15 mg/kg iv day 1 of a 21-day cycle till unacceptable toxicity or disease progression.


Locations(3)

NKI-AvL

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06401824


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