The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. The key secondary objectives are: Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
790
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
Platinum-based doublet chemotherapy Part 1
Matching placebo Part 2
Regeneron Research Site
Rancho Mirage, California, United States
Regeneron Research Site
Riverside, California, United States
Regeneron Research Site
Whittier, California, United States
Regeneron Research Site
Orange City, Florida, United States
Regeneron Research Site
St. Petersburg, Florida, United States
Overall survival
Time frame: Up to 32 months
Progression-free survival
Time frame: Up to 32 months
Objective response rate
Time frame: Up to 32 months
Duration of Response (DOR)
Time frame: Up to 32 months
Best overall response (BOR)
Time frame: Up to 32 months
Incidence of Treatment-emergent adverse events (TEAEs)
Time frame: Up to 32 months
Incidence of Dose-limiting toxicities (DLTs)
Part 1 only
Time frame: Up to 32 months
Incidence of serious adverse events (SAEs)
Time frame: Up to 32 months
Incidence of deaths
Time frame: Up to 32 months
Incidence of laboratory abnormalities
Time frame: Up to 32 months
Overall survival rate
Time frame: 12 months
Overall survival rate
Time frame: 18 months
Overall survival rate
Time frame: 24 months
Quality of life as measured by EORTC QLQ-C30
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Up to 32 months
Quality of life as measured by EORTC QLQ-LC13
Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Time frame: Up to 32 months
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Regeneron Research Site
Wichita, Kansas, United States
Regeneron Research Site
Bethesda, Maryland, United States
Regeneron Research Site
Farmington, New Mexico, United States
Regeneron Research Site
Gettysburg, Pennsylvania, United States
Regeneron Research Site
Vienna, Austria
...and 123 more locations