A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2021-10-27

Brief Summary

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The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in \<50% of tumor cells.

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Detailed Description

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Conditions

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Advanced Non-Small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SDREGN2810

Group Type EXPERIMENTAL

SDREGN2810

Intervention Type DRUG

Standard dose intravenous (IV) infusion

SDREGN2810/ipi

Group Type EXPERIMENTAL

SDREGN2810/ipi

Intervention Type DRUG

Combination therapy dose IV

HDREGN2810

Group Type EXPERIMENTAL

HDREGN2810

Intervention Type DRUG

High dose IV

Interventions

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SDREGN2810

Standard dose intravenous (IV) infusion

Intervention Type DRUG

SDREGN2810/ipi

Combination therapy dose IV

Intervention Type DRUG

HDREGN2810

High dose IV

Intervention Type DRUG

Other Intervention Names

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REGN2810 cemiplimab REGN2810 cemiplimab ipilimumab REGN2810 cemiplimab

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC who either have stage IIIb or stage IIIc disease who are not candidates for treatment with definitive concurrent chemo-radiation or have stage IV disease. Patients must have PD after receiving one prior line of chemotherapy treatment for advanced NSCLC.
2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample
3. Biopsy evaluable for expression of PD-L1 as determined by a PD-L1 Immunohistochemistry (IHC) pharma diagnostic test (pharmDx) assay performed by a central laboratory
4. At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

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 randomization
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), or 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 a risk of immunerelated treatment-emergent adverse events (irTEAEs)
7. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No