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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Administered per the protocol
Administered per the protocol
Administered per the protocol
Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 5 years
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
Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1
Time frame: Up to 5 years
Incidence of Anti-Drug Antibodies (ADA) to ubamatamab
Time frame: Up to 5 years
Incidence of ADA to REGN7075
Time frame: Up to 5 years
Magnitude of ADA to ubamatamab
Time frame: Up to 5 years
Magnitude of ADA to REGN7075
Time frame: Up to 5 years
Concentrations of ubamatamab in serum
Time frame: Up to 5 years
Concentrations of REGN7075 in serum
Time frame: Up to 5 years
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