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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
Search all trials

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
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
Are there results?
Not yet: the study is under way

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
Show all 9Show fewer
  • 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

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)

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
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 groupRoleWhat they receive
Arm 1AExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Sarilumab
Arm 1BExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Marlotamig; Drug: Sarilumab
Arm 1CExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Marlotamig; Drug: Sarilumab
Arm 2AExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Sarilumab
Arm 2BExperimentalNot described
Receives: Drug: Ubamatamab; Drug: Marlotamig; Drug: Sarilumab
Arm 2CExperimentalNot 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.

  1. 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)

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to 5 years

  2. Severity of TEAEs

    Measured: Up to 5 years

  3. Occurrence of Treatment-Related Adverse Events (TRAEs)

    Measured: Up to 5 years

  4. Severity of TRAEs

    Measured: Up to 5 years

  5. Occurrence of Adverse Events of Special Interest (AESIs)

    Measured: Up to 5 years

  6. Severity of AESIs

    Measured: Up to 5 years

  7. Occurrence of Serious Adverse Events (SAEs)

    Measured: Up to 5 years

  8. Severity of SAEs

    Measured: Up to 5 years

  9. Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria

    Measured: Up to 5 years

  10. Duration of Response (DOR) as assessed by the investigator per RECIST v1.1

    Measured: Up to 5 years

  11. Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1

    Measured: Up to 5 years

  12. Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1

    Measured: Up to 5 years

  13. Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1

    Measured: Up to 5 years

  14. Incidence of Anti-Drug Antibodies (ADA) to ubamatamab

    Measured: Up to 5 years

  15. Incidence of ADA to marlotamig

    Measured: Up to 5 years

  16. Magnitude of ADA to ubamatamab

    Measured: Up to 5 years

  17. Magnitude of ADA to marolotamig

    Measured: Up to 5 years

  18. Concentrations of ubamatamab in serum

    Measured: Up to 5 years

  19. 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.

  1. First posted4 Sep 2025
  2. Study start18 Mar 2026
  3. Primary completion10 Jun 2030 (estimated)
  4. Study completion10 Jun 2030 (estimated)

Resources

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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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