REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/22/2018
Start Date:March 6, 2018
End Date:July 18, 2022
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com
Phone:844-734-6643

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A Randomized, Phase 3, Open-label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50%

The primary objective is to compare the progression-free survival (PFS) of cemiplimab plus
platinum-based doublet chemotherapy combination therapy (cemiplimab/chemo) and cemiplimab
plus platinum-based doublet chemotherapy plus ipilimumab combination therapy
(cemiplimab/chemo/ipi) with standard-of-care platinum-based doublet chemotherapy in the
first-line treatment of patients with advanced squamous or non-squamous non-small cell lung
cancer (NSCLC) in the subgroup of patients whose tumors express programmed cell death ligand
1 (PD-L1) in 1% to <50% of tumor cells and in the overall population of study patients whose
tumors express PD-L1 in <50% of tumor cells.

The key secondary objectives are:

- To compare the Overall Survival (OS) of cemiplimab/chemo and cemiplimab/chemo/ipi versus
standard-of-care platinum-based doublet chemotherapy in the first-line treatment of
patients with advanced squamous or non-squamous NSCLC in the subgroup of patients whose
tumors express PD-L1 in 1% to <50% of tumor cells and in the overall population of study
patients whose tumors express PD-L1 in <50% of tumor cells

- To compare the ORR of cemiplimab/chemo and cemiplimab/chemo/ipi versus standard-of-care
platinum-based doublet chemotherapy in the first-line treatment of patients with
advanced squamous or non-squamous NSCLC in the subgroup of patients whose tumors express
PD-L1 in 1% to <50% of tumor cells and in the overall population of study patients whose
tumors express PD-L1 in <50% of tumor cells

- To evaluate the safety and tolerability of cemiplimab/chemo and cemiplimab/chemo/ipi
compared to standard-of-care platinum-based doublet chemotherapy


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 chemoradiation or patients with stage IV disease if they have
not received prior systemic treatment for recurrent or metastatic NSCLC

2. Availability of an archival (≤5 months) or on-study obtained formalin-fixed,
paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has
not previously been irradiated

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

Key Exclusion Criteria:

1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime

2. Active or untreated brain metastases or spinal cord compression

3. Patients with tumors tested positive for Epidermal growth factor receptor (EGFR) gene
mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene
receptor tyrosine kinase(ROS1) fusions

4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment

5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing
pneumonia), of active, noninfectious pneumonitis that required immune-suppressive
doses of glucocorticoids to assist with management, or of pneumonitis within the last
5 years

6. Ongoing or recent evidence of significant autoimmune disease that required treatment
with systemic immunosuppressive treatments, which may suggest risk of immune-related
treatment-emergent adverse events (irTEAEs)

7. Previous treatment with idelalisib at any time (ZYDELIG®)

8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or
equivalent) within 14 days of randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
13
sites
Orange City, Florida 32763
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Orange City, FL
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Bethesda, Maryland 20817
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Bethesda, MD
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Farmington, New Mexico 87401
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Farmington, NM
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Gettysburg, Pennsylvania 17325
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Gettysburg, PA
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Hot Springs, Arkansas 71913
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Hot Springs, AR
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Las Vegas, Nevada
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Las Vegas, NV
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Mont-de-Marsan, 40024
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Mont-de-Marsan,
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New Albany, Indiana 47150
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New Albany, IN
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Quincy, Illinois 62301
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Quincy, IL
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Rancho Mirage, California 92270
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Rancho Mirage, CA
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Saint Petersburg, Florida 33709
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Saint Petersburg, FL
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Wichita, Kansas 67214
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Wichita, KS
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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