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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1A | Experimental |
| |
| Arm 1B | Experimental |
| |
| Arm 1C | Experimental |
| |
| Arm 2A | Experimental |
| |
| Arm 2B | Experimental |
| |
| Arm 2C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubamatamab | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to 5 years | |
| Severity of TEAEs | Up to 5 years | |
| Occurrence of Treatment-Related Adverse Events (TRAEs) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion / exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Treatment Centers of America, Phoenix | Recruiting | Goodyear | Arizona | 85338 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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|
| REGN7075 | Drug | Administered per the protocol |
|
| Sarilumab | Drug | Administered per the protocol |
|
|
| Up to 5 years |
| Severity of TRAEs | Up to 5 years |
| Occurrence of Adverse Events of Special Interest (AESIs) | Up to 5 years |
| Severity of AESIs | Up to 5 years |
| Occurrence of Serious Adverse Events (SAEs) | Up to 5 years |
| Severity of SAEs | Up to 5 years |
| Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria | Up to 5 years |
| Duration of Response (DOR) as assessed by the investigator per RECIST v1.1 | Up to 5 years |
| Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1 | Up to 5 years |
| Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1 | Up to 5 years |
| Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1 | Up to 5 years |
| Incidence of Anti-Drug Antibodies (ADA) to ubamatamab | Up to 5 years |
| Incidence of ADA to REGN7075 | Up to 5 years |
| Magnitude of ADA to ubamatamab | Up to 5 years |
| Magnitude of ADA to REGN7075 | Up to 5 years |
| Concentrations of ubamatamab in serum | Up to 5 years |
| Concentrations of REGN7075 in serum | Up to 5 years |
| The City of Hope Orange County Lennar Foundation Cancer Center |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| University of Illinois Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
| Franciscan Health | Recruiting | Munster | Indiana | 46321 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Recruiting | Baltimore | Maryland | 21201 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| University of Texas Medical Branch | Recruiting | Galveston | Texas | 77555 | United States |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Baylor Scott & White Health | Recruiting | Temple | Texas | 76508 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000592401 | sarilumab |
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