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NCT07154290From ClinicalTrials.govRecruiting

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)

  • Non Small Cell Lung Cancer
  • Advanced Non Small Cell Lung Cancer
  • Metastatic Non Small Cell Lung Cancer
  • Carcinoma Non Small Cell Lung

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Regeneron Pharmaceuticals
Enrolment target
300
Started
18 March 2026
Main results due
10 June 2030
Study sites
17
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Key Inclusion Criteria:

1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC
2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol
3. 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
4. Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol
5. 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
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

1. Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
2. 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)
3. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
4. 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
5. Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention
6. Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol
7. Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention
8. 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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(17)

  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

    Recruiting

  • Cancer Treatment Centers of America, Phoenix

    Goodyear, Arizona, United States

    Recruiting

  • The City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, United States

    Recruiting

  • ChristianaCare Health System

    Newark, Delaware, United States

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, United States

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, United States

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, United States

    Recruiting

  • University of Illinois Chicago

    Chicago, Illinois, United States

    Recruiting

  • Franciscan Health

    Munster, Indiana, United States

    Recruiting

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, United States

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, United States

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, United States

    Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee, United States

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, United States

    Recruiting

  • University of Texas Medical Branch

    Galveston, Texas, United States

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, United States

    Recruiting

  • Baylor Scott & White Health

    Temple, Texas, United States

    Recruiting

Showing 17 of 17 sites. 17 of the 17 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07154290. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/M | Trialion