A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Not Applicable
Not yet recruiting
- Conditions
- Advanced/Metastatic Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT07154290
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
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
Key
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1A Ubamatamab - Arm 1B Sarilumab - Arm 1A Sarilumab - Arm 1B Ubamatamab - Arm 1B REGN7075 - Arm 1C REGN7075 - Arm 1C Sarilumab - Arm 2A Ubamatamab - Arm 2A Sarilumab - Arm 1C Ubamatamab - Arm 2B Ubamatamab - Arm 2B REGN7075 - Arm 2B Sarilumab - Arm 2C Ubamatamab - Arm 2C Sarilumab - Arm 2C REGN7075 -
- Primary Outcome Measures
Name Time Method Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to 5 years
- Secondary Outcome Measures
Name Time Method 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 Severity of AESIs Up to 5 years Occurrence of Serious Adverse Events (SAEs) Up to 5 years Severity of SAEs Up to 5 years Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria Up to 5 years Duration of Response (DOR) as assessed by the investigator per RECIST v1.1 Up to 5 years Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1 Up to 5 years Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1 Up to 5 years Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1 Up to 5 years Incidence of Anti-Drug Antibodies (ADA) to ubamatamab Up to 5 years Incidence of ADA to REGN7075 Up to 5 years Magnitude of ADA to ubamatamab Up to 5 years Magnitude of ADA to REGN7075 Up to 5 years Concentrations of ubamatamab in serum Up to 5 years Concentrations of REGN7075 in serum Up to 5 years