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A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03430063
Recruitment Status : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Non-Small Cell Lung Carcinoma Drug: SDREGN2810 Drug: SDREGN2810/ipi Drug: HDREGN2810 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: SDREGN2810 Drug: SDREGN2810
Standard dose intravenous (IV) infusion
Other Names:
  • REGN2810
  • cemiplimab

Experimental: SDREGN2810/ipi Drug: SDREGN2810/ipi
Combination therapy dose IV
Other Names:
  • REGN2810
  • cemiplimab
  • ipilimumab

Experimental: HDREGN2810 Drug: HDREGN2810
High dose IV
Other Names:
  • REGN2810
  • cemiplimab




Primary Outcome Measures :
  1. ORR [ Time Frame: Up to 31 months ]
    Proportion of patients achieving complete response (CR) or partial response (PR) as assessed by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in patients whose tumors express PD-L1 in <50% of tumor cells


Secondary Outcome Measures :
  1. ORR in all patients [ Time Frame: Up to 31 months ]
  2. Overall survival (OS) in patients whose tumors express PD-L1 in <50% of tumor cells [ Time Frame: Up to 31 months ]
  3. OS in all patients [ Time Frame: Up to 31 months ]
  4. Progression free survival (PFS) in patients whose tumors express PD-L1 in <50% of tumor cells [ Time Frame: Up to 31 months ]
  5. PFS in all patients [ Time Frame: Up to 31 months ]
  6. Incidences of treatment emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system [ Time Frame: Up to 31 months ]
  7. Incidences of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system [ Time Frame: Up to 31 months ]
  8. Incidences of deaths [ Time Frame: Up to 31 months ]
  9. Incidences of laboratory abnormalities as assessed by the NCI-CTCAE grading system [ Time Frame: Up to 31 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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

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 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

Note: Other protocol defined Inclusion/Exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430063


  Show 31 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03430063     History of Changes
Other Study ID Numbers: R2810-ONC-1763
2017-003684-35 ( EudraCT Number )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Regeneron Pharmaceuticals:
Advanced non-squamous NSCLC
Advanced squamous NSCLC

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ipilimumab
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents