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

Official title

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

Overview

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

Interventions

• Drug Ubamatamab
  Administered per the protocol
• Drug REGN7075
  Administered per the protocol
• Drug Sarilumab
  Administered per the protocol

Primary outcome measures

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

Secondary outcome measures (12)

• Occurrence of Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 5 years]
• Severity of TEAEs [Time frame: Up to 5 years]
• Occurrence of Treatment-Related Adverse Events (TRAEs) [Time frame: Up to 5 years]
• Severity of TRAEs [Time frame: Up to 5 years]
• Occurrence of Adverse Events of Special Interest (AESIs) [Time frame: Up to 5 years]
• Severity of AESIs [Time frame: Up to 5 years]
• Occurrence of Serious Adverse Events (SAEs) [Time frame: Up to 5 years]
• Severity of SAEs [Time frame: Up to 5 years]
• Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria [Time frame: Up to 5 years]
• Duration of Response (DOR) as assessed by the investigator per RECIST v1.1 [Time frame: Up to 5 years]
• Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1 [Time frame: Up to 5 years]
• Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1 [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

NOTE: Other protocol defined inclusion / exclusion criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 12 centers

• Cancer Treatment Centers of America, Phoenix — Goodyear
• The City of Hope Orange County Lennar Foundation Cancer Center — Irvine
• Rush University Medical Center — Chicago
• University of Illinois Chicago — Chicago
• Franciscan Health — Munster
• University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore
• Washington University School of Medicine — St Louis
• University of Tennessee Medical Center — Knoxville
• … and 4 more centers

Identifiers

NCT: NCT07154290 · R4018-ONC-2476

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗