Non-small Cell Lung Cancer
Conditions
Interventions
- Drug: REGN2810/ipi: REGN2810 plus ipilimumab (cemiplimab), Intravenous (IV) infusion
- Drug: REGN2810/chemo/ipi: REGN2810 plus chemotherapy plus Ipilimumab (cemiplimab), Intravenous (IV) infusio
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: 1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB, or IIIC disease who are not candidates for treatment with definitive concurrent chemo/radiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC. 2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample 3. Expression of PD-L1 in >=50% of tumor cells determined by the commercially available assay performed by the central laboratory 4. At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site 5. Eastern Cooperative Oncology Group (ECOG) performance status of <=1 6. Anticipated life expectancy of at least 3 months
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: 1. Patients who have never smoked, defined as smoking 10 mg prednisone/day or equivalent) within 14 days of randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. PFS as assessed by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival (OS) 2. Objective response rate (ORR) 3. Incidence of Treatment-emergent adverse events (TEAEs) 4. Incidence of Dose-limiting toxicities (DLTs) 5. Incidence of serious adverse events (SAEs) 6. Incidence of deaths 7. Incidence of laboratory abnormalities 8. Quality of life (Core 30 Questionnaire) As measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) four-point scale, with 1 as "not at all" and 4 as "very much" efficacy 9. Quality of life (Lung Cancer 13 Questionnaire) As measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much". | — |
Countries
Italy, Lithuania, United States
Contacts
Public ContactAdministrator Clinical
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed