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

NCT07154290 | Recruiting Phase 2 FDA Drug

• 1 other identifier: R4018-ONC-2476
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate two study drugs called ubamatamab and REGN7075, 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 REGN7075 works
• The side effects that ubamatamab and REGN7075 might cause
• How much ubamatamab and REGN7075 is in the blood at different times
• If the body makes antibodies to ubamatamab and/or REGN7075, this may cause the ubamatamab to not work as well

Conditions

Advanced/Metastatic Non-Small Cell Lung Cancer

Keywords

NSCLC; Mucin-16 (MUC16); Ubamatamab; Epidermal Growth Factor Receptor (EGFR); REGN7075; Stage IIIB, IIIC or IV

Outcome Measures

Primary Outcomes (1)

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

  Up to 5 years

Secondary Outcomes (19)

• Occurrence of Treatment Emergent Adverse Events (TEAEs)

  Up to 5 years

• Severity of TEAEs

  Up to 5 years

• Occurrence of Treatment-Related Adverse Events (TRAEs)

  Up to 5 years

• Severity of TRAEs

  Up to 5 years

• Occurrence of Adverse Events of Special Interest (AESIs)

  Up to 5 years

Study Arms (6)

Arm 1A

EXPERIMENTAL

Drug: Ubamatamab; Drug: Sarilumab

Arm 1B

EXPERIMENTAL

Drug: Ubamatamab; Drug: REGN7075; Drug: Sarilumab

Arm 1C

EXPERIMENTAL

Drug: Ubamatamab; Drug: REGN7075; Drug: Sarilumab

Arm 2A

EXPERIMENTAL

Drug: Ubamatamab; Drug: Sarilumab

Arm 2B

EXPERIMENTAL

Drug: Ubamatamab; Drug: REGN7075; Drug: Sarilumab

Arm 2C

EXPERIMENTAL

Drug: Ubamatamab; Drug: REGN7075; Drug: Sarilumab

Interventions

Ubamatamab DRUG

Administered per the protocol

Also known as: REGN4018

Arm 1A; Arm 1B; Arm 1C; Arm 2A; Arm 2B; Arm 2C

REGN7075 DRUG

Administered per the protocol

Arm 1B; Arm 1C; Arm 2B; Arm 2C

Sarilumab DRUG

Administered per the protocol

Also known as: REGN88SAR153191

Arm 1A; Arm 1B; Arm 1C; Arm 2A; Arm 2B; Arm 2C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): June 24, 2030
• Study Completion (Estimated): June 24, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (1)