Actively Recruiting
Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases
Led by Maastricht University Medical Center · Updated on 2025-05-06
25
Participants Needed
3
Research Sites
101 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained before participation
- Adult aged 18 years or older at consent
- ECOG performance status 0 or 1
- Estimated life expectancy of at least 12 weeks
- Pathology-confirmed metastatic non-squamous NSCLC
- For patients without actionable oncogenic drivers: progression after immunotherapy and/or platinum-doublet chemotherapy
- For patients with actionable oncogenic drivers: progression after targeted therapy and platinum-doublet chemotherapy
- Brain metastases not located in eloquent brain areas
- Maximum brain metastasis size 2 cm in longest diameter
- At least one untreated brain metastasis 5 mm or larger
- Patients asymptomatic from CNS metastases and on stable corticosteroid dose (max 4 mg dexamethasone daily) for at least 7 days before treatment
- Recovery from prior treatment toxicities to grade 1 or less (except alopecia and neuropathy)
- Adequate organ function as shown by specific laboratory values
- Ability to follow study instructions and communicate with investigators
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception
You will not qualify if you...
- Presence of leptomeningeal metastasis
- Previous treatment with TROP2 or angiogenesis inhibitors
- Known allergy to study drugs or their components
- Positive pregnancy test or breastfeeding
- Contraindication to MRI
- History of bone marrow or solid organ transplant
- Recent anticancer biologic agents, chemotherapy, targeted therapy, or radiation within specified timeframes without recovery
- Active second malignancy except certain low-risk cancers
- Recent serious cardiac events or severe heart conditions
- Active inflammatory bowel disease or recent gastrointestinal perforation
- Active serious infection requiring antibiotics
- Known HIV infection with detectable viral load or interfering medications
- Active hepatitis B or C infection with detectable viral load
- Other medical or psychiatric conditions affecting study participation
- Use of other investigational drugs within 28 days or 5 half-lives
- Severe pulmonary problems or prior pneumonectomy
- Specific contraindications for bevacizumab including uncontrolled hypertension, vascular disease, recent bleeding events, coagulopathy, recent surgery, gastrointestinal issues, non-healing wounds, significant proteinuria, tumor invasion of major vessels, or pulmonary lesion cavitation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
NKI-AvL
Amsterdam, Netherlands
Actively Recruiting
2
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
3
Maastricht University Medical Center
Maastricht, Netherlands
Actively Recruiting
Research Team
L
Lizza Hendriks, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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