Actively Recruiting
A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Led by Regeneron Pharmaceuticals · Updated on 2026-05-07
300
Participants Needed
4
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate two study drugs called ubamatamab and REGN7075, to see if they can help treat advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), and sarilumab, to evaluate to see if it can help with immune-related side effects from ubamatamab. The study is looking at: * How well ubamatamab and REGN7075 works * The side effects that ubamatamab and REGN7075 might cause * How much ubamatamab and REGN7075 is in the blood at different times * If the body makes antibodies to ubamatamab and/or REGN7075, this may cause the ubamatamab to not work as well
CONDITIONS
Official Title
A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with confirmed advanced (stage IIIB or IIIC) or metastatic (stage IV) Non-Small Cell Lung Cancer
- Received appropriate first-line standard treatment for advanced or metastatic NSCLC
- If not given platinum doublet chemotherapy first, must have received it later unless not appropriate
- Have tumor tissue available for testing MUC16 expression by immunohistochemistry
- Have at least one measurable tumor lesion by CT or MRI, including previously irradiated sites with progression
- Have an ECOG performance status of 0 or 1
You will not qualify if you...
- Disease progression less than 84 days after starting initial anti-PD-(L)1 therapy
- Unresolved toxicity from prior treatments above grade 1 (except certain exceptions like alopecia or controlled endocrinopathy)
- Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
- Participation in another investigational study with intervention within 4 weeks before study drug
- Prior monoclonal antibody against PD-(L)1 within 21 days before study drug
- Other prior anti-cancer immunotherapy within 21 days before study drug
- Cytotoxic chemotherapy within 21 days before study drug
- Anti-EGFR antibody therapy within a specified drug-specific window before study drug
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cancer Treatment Centers of America, Phoenix
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
3
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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