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NCT07154290RecruitingPhase 2

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

A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
300 (estimated)
First submitted
26 Aug 2025
Start date
18 Mar 2026
Primary completion date
10 Jun 2030
Lead sponsor
Regeneron Pharmaceuticals
Diseases
Lung cancer
NCT number
NCT07154290

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 300
  • From 18 Mar 2026 to the primary completion date, 10 Jun 2030
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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

Other illness

  • Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
  • Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Maryland Greenebaum Comprehensive Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
University of Alabama at Birmingham
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BirminghamUnited StatesRecruiting
Rush University Medical Center
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ChicagoUnited StatesRecruiting
University of Illinois Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Texas Medical Branch
Coordinator of this site? Confirm its status
GalvestonUnited StatesRecruiting
Cancer Treatment Centers of America, Phoenix
Coordinator of this site? Confirm its status
GoodyearUnited StatesRecruiting
The University of Texas MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
The City of Hope Orange County Lennar Foundation Cancer Center
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IrvineUnited StatesRecruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesRecruiting
University of Tennessee Medical Center
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KnoxvilleUnited StatesRecruiting
Franciscan Health
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MunsterUnited StatesRecruiting
Sarah Cannon Research Institute
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NashvilleUnited StatesRecruiting
ChristianaCare Health System
Coordinator of this site? Confirm its status
NewarkUnited StatesRecruiting
Oregon Health and Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Baylor Scott & White Health
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TempleUnited StatesRecruiting
Georgetown University
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.