Advanced/Metastatic Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, Mucin-16 (MUC16), Ubamatamab, Epidermal Growth Factor Receptor (EGFR), REGN7075, Stage IIIB, IIIC or IV
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
Interventions
DRUGUbamatamab
Administered per the protocol
DRUGREGN7075
Administered per the protocol
DRUGSarilumab
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC 2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol 3. 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 4. Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol 5. 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 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Key
Exclusion criteria
1. Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy 2. 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) 3. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol 4. 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 5. Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention 6. Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol 7. Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention 8. 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 /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed