Study on Ubamatamab With and Without REGN7075 for Treating Advanced Non-Small Cell Lung Cancer
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT07154290
This clinical trial is testing two new drugs, ubamatamab and REGN7075, to see if they can help treat advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). The study also looks at using sarilumab to manage immune-related side effects from ubamatamab.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well the drugs ubamatamab and REGN7075 work in treating advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Researchers will also study the side effects these drugs might cause, how much of the drugs are in the blood at different times, and whether the body makes antibodies that could affect how well the drugs work.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).
- Have received appropriate first-line treatment for advanced or metastatic NSCLC.
- If not given platinum doublet chemotherapy as first-line treatment, it should be given later unless there's a reason it's not suitable.
- Have tumor tissue available for testing a specific protein (MUC16) using a lab test.
- Have at least one tumor that can be measured by a scan (CT or MRI).
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
Exclusion Criteria
- Disease progression within 84 days of starting initial PD-(L)1 therapy.
- Unresolved side effects from previous treatments, except for hair loss, hearing loss, mild nerve damage, or hormone-managed conditions.
- Have untreated or active brain tumors or cancer spread to the brain or spinal cord.
- Participated in another study with an investigational treatment within 4 weeks before starting this study.
- Received a PD-(L)1 antibody treatment within 21 days before starting this study.
- Had other cancer immunotherapy within 21 days before starting this study.
- Received chemotherapy within 21 days before starting this study.
- Received anti-EGFR antibody therapy within a specific time frame before starting this study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer Treatment Centers of America, Phoenix | 85338 | Goodyear | Arizona |
| The City of Hope Orange County Lennar Foundation Cancer Center | 92618 | Irvine | California |
| Franciscan Health | 46321 | Munster | Indiana |
| University of Maryland Greenebaum Comprehensive Cancer Center | 21201 | Baltimore | Maryland |
| University of Tennessee Medical Center | 37920 | Knoxville | Tennessee |
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