Non Small Cell Lung CancerPhase 2NCT07154290

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 testing Ubamatamab, Marlotamig and Sarilumab in people with Non Small Cell Lung Cancer and Advanced Non Small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 18 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
What is being tested?: Ubamatamab, Marlotamig and Sarilumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 18 sitesUnited States
Study dates: 18 Mar 2026to 10 Jun 2030
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

City, postcode or hospital

Sites recruiting now only

18 sites in 1 country

United States18 sites, 18 recruiting

University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Recruiting
Cancer Treatment Centers of America, Phoenix
Goodyear, Arizona, 85338
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Recruiting
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Recruiting
Franciscan Health
Munster, Indiana, 46321
Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Recruiting
ChristianaCare Health System
Newark, Delaware, 19713
Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Recruiting
Baylor Scott & White Health
Temple, Texas, 76508
Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
Recruiting

Other trials in United States

About this study

Official title: 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)

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

Conditions: Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer, Carcinoma Non Small Cell Lung
Being tested: Ubamatamab, Marlotamig, Sarilumab
Keywords: Mucin-16 (MUC16), Ubamatamab, Epidermal Growth Factor Receptor (EGFR), REGN7075, Stage IIIB, IIIC or IV, Marlotamig, NSCLC, Advanced NSCLC, Metastatic NSCLC, Lung Cancer, Advanced Lung Cancer, Metastatic Lung Cancer, Stage IV NSCLC, Recurrent NSCLC, Unresectable NSCLC
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UbamatamabDrug
Also called REGN4018
Administered per the protocol
MarlotamigDrug
Also called REGN7075
Administered per the protocol
SarilumabDrug
Also called REGN88SAR153191, KEVZARA®
Administered per the protocol

Study groups in NCT07154290
Study group	Role	What they receive
Arm 1A	Experimental	Not described Receives: Drug: Ubamatamab; Drug: Sarilumab
Arm 1B	Experimental	Not described Receives: Drug: Ubamatamab; Drug: Marlotamig; Drug: Sarilumab
Arm 1C	Experimental	Not described Receives: Drug: Ubamatamab; Drug: Marlotamig; Drug: Sarilumab
Arm 2A	Experimental	Not described Receives: Drug: Ubamatamab; Drug: Sarilumab
Arm 2B	Experimental	Not described Receives: Drug: Ubamatamab; Drug: Marlotamig; Drug: Sarilumab
Arm 2C	Experimental	Not described Receives: Drug: Ubamatamab; Drug: Marlotamig; Drug: Sarilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (19)

Occurrence of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 5 years
Severity of TEAEs
Measured: Up to 5 years
Occurrence of Treatment-Related Adverse Events (TRAEs)
Measured: Up to 5 years
Severity of TRAEs
Measured: Up to 5 years
Occurrence of Adverse Events of Special Interest (AESIs)
Measured: Up to 5 years
Severity of AESIs
Measured: Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
Measured: Up to 5 years
Severity of SAEs
Measured: Up to 5 years
Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria
Measured: Up to 5 years
Duration of Response (DOR) as assessed by the investigator per RECIST v1.1
Measured: Up to 5 years
Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1
Measured: Up to 5 years
Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1
Measured: Up to 5 years
Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1
Measured: Up to 5 years
Incidence of Anti-Drug Antibodies (ADA) to ubamatamab
Measured: Up to 5 years
Incidence of ADA to marlotamig
Measured: Up to 5 years
Magnitude of ADA to ubamatamab
Measured: Up to 5 years
Magnitude of ADA to marolotamig
Measured: Up to 5 years
Concentrations of ubamatamab in serum
Measured: Up to 5 years
Concentrations of marlotamig in serum
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 202610 Jun 2030

First posted4 Sep 2025
Study start18 Mar 2026
Primary completion10 Jun 2030 (estimated)
Study completion10 Jun 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07154290
Sponsor's protocol ID: R4018-ONC-2476
Status last verified: Oct 2026
First submitted: 26 Aug 2025
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Interested in taking part?

Clinical Trials Administrator

844-734-6643

clinicaltrials@regeneron.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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