A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Recruiting · NCT07154290 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study will evaluate two study drugs called ubamatamab and marlotamig, 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 marlotamig work(s) * The side effects that ubamatamab and marlotamig might cause * How much ubamatamab and marlotamig is in the blood at different times * If the body makes antibodies to ubamatamab and/or marlotamig, this may cause the ubamatamab to not work as well
Who can take part
Inclusion criteria
- Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC
- Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol
- If platinum doublet chemotherapy was not administered as first line therapy, it is required in a later line of therapy prior to enrollment unless there is a documented reason why it is not appropriate
- Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol
- Has at least 1 radiographically measurable lesion by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST v1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Key
Exclusion criteria
- Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
- Experienced toxicity related to prior treatment that has not resolved to grade 1 prior to initiation of study intervention (except alopecia, hearing loss, grade 2 neuropathy, or endocrinopathy managed with hormone replacement therapy)
- Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
- Current participation OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical study
- Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention
- Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol
- Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention
- Has received an anti-EGFR antibody therapy within the following drug-specific window prior to first dose of study intervention (approximately 5 half-lives), as described in the protocol
- NOTE: Other protocol defined inclusion / exclusion criteria apply
Where it is running
16 locations listed across 12 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Cancer Treatment Centers of America, Phoenix - Goodyear, Arizona, United States
- The City of Hope Orange County Lennar Foundation Cancer Center - Irvine, California, United States
- Georgetown University - Washington D.C., District of Columbia, United States
- Mayo Clinic Jacksonville - Jacksonville, Florida, United States
- Rush University Medical Center - Chicago, Illinois, United States
- University of Illinois Chicago - Chicago, Illinois, United States
- Franciscan Health - Munster, Indiana, United States
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore, Maryland, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- University of Tennessee Medical Center - Knoxville, Tennessee, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- University of Texas Medical Branch - Galveston, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Baylor Scott & White Health - Temple, Texas, United States