A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Key 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

ubamatamab. A bispecific, human monoclonal antibody with potential antineoplastic activity. REGN4018 contains two antigen-recognition sites: one for human CD3, a T-cell surface antigen that is part of the T-cell receptor complex, and one for human mucin 16 (MUC16, cancer antigen 125; CA125; FLJ14303), a member of the mucin family of glycoproteins that is overexpressed by several epithelial cancers, including ovarian cancer. Upon administration, ubamatamab binds to both T cells and MUC16-expressing tumor cells, which cross-links the T cells to the tumor cells, and may result in a potent cytotoxic T-lymphocyte (CTL) response against the MUC16-expressing tumor cells. NCI Drug Dictionary

marlotamig. A bispecific antibody directed against both human epidermal growth factor receptor (EGFR) and the co-stimulatory T-cell-specific surface glycoprotein CD28, with potential immunostimulating and antineoplastic activities. Upon administration of marlotamig, this bispecific antibody binds to both CD28 on cytotoxic T lymphocytes (CTLs) and EGFR found on EGFR-expressing tumor cells. This activates and redirects CTLs to EGFR-expressing tumor cells, which may result in the CTL-mediated cell death of EGFR-expressing tumor cells. EGFR, a member of the epidermal growth factor receptor family, is overexpressed on various tumor cell types. NCI Drug Dictionary

Treatments listed in the registry

• Ubamatamab (Drug): Administered per the protocol
• Marlotamig (Drug): Administered per the protocol
• Sarilumab (Drug): Administered per the protocol

Randomized · Parallel · masking: None

Main goals

• Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Up to 5 years)

Other goals

• Occurrence of Treatment Emergent Adverse Events (TEAEs)
• Severity of TEAEs
• Occurrence of Treatment-Related Adverse Events (TRAEs)
• Severity of TRAEs
• Occurrence of Adverse Events of Special Interest (AESIs)
• Severity of AESIs
• Occurrence of Serious Adverse Events (SAEs)
• Severity of SAEs
• Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria
• Duration of Response (DOR) as assessed by the investigator per RECIST v1.1
• Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1
• Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1
• Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1
• Incidence of Anti-Drug Antibodies (ADA) to ubamatamab
• Incidence of ADA to marlotamig
• Magnitude of ADA to ubamatamab
• Magnitude of ADA to marolotamig
• Concentrations of ubamatamab in serum
• Concentrations of marlotamig in serum

Planned enrollment: 300 (estimated).

• University of Alabama at Birmingham, Birmingham, Alabama
• Cancer Treatment Centers of America, Phoenix, Goodyear, Arizona
• The City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California
• ChristianaCare Health System, Newark, Delaware
• Georgetown University, Washington D.C., District of Columbia
• Mayo Clinic Jacksonville, Jacksonville, Florida
• Rush University Medical Center, Chicago, Illinois
• University of Illinois Chicago, Chicago, Illinois
• Franciscan Health, Munster, Indiana
• University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland
• Mayo Clinic, Rochester, Minnesota
• Washington University School of Medicine, St Louis, Missouri
• Oregon Health and Science University, Portland, Oregon
• University of Tennessee Medical Center, Knoxville, Tennessee
• Sarah Cannon Research Institute, Nashville, Tennessee
• University of Texas Medical Branch, Galveston, Texas
• The University of Texas MD Anderson Cancer Center, Houston, Texas
• Baylor Scott & White Health, Temple, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07154290
• NCI Drug Dictionary: C153129
• NCI Drug Dictionary: C178284

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 21, 2026. Public record; not medical advice.