Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 38 for:    cemiplimab

REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy 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: NCT03515629
Recruitment Status : Active, not recruiting
First Posted : May 3, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: REGN2810/ipi Drug: REGN2810/chemo/ipi Drug: Pembrolizumab Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 ≥50%
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : November 18, 2020
Estimated Study Completion Date : November 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Pembrolizumab
Pembrolizumab
Drug: Pembrolizumab
Reference drug administered IV infusion

Experimental: REGN2810/ipi
REGN2810/ipi
Drug: REGN2810/ipi
REGN2810 plus ipilimumab
Other Name: cemiplimab

Experimental: REGN2810/chemo/ipi
REGN2810/chemo/ipi
Drug: REGN2810/chemo/ipi
REGN2810 plus chemotherapy plus Ipilimumab
Other Name: cemiplimab




Primary Outcome Measures :
  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 [ Time Frame: Up to 32 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 32 months ]
  2. Objective response rate (ORR) [ Time Frame: Up to 32 months ]
  3. Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 32 months ]
  4. Incidence of Dose-limiting toxicities (DLTs) [ Time Frame: Up to 32 months ]
  5. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 32 months ]
  6. Incidence of deaths [ Time Frame: Up to 32 months ]
  7. Incidence of laboratory abnormalities [ Time Frame: Up to 32 months ]
  8. Overall survival [ Time Frame: 12 months ]
  9. Overall survival [ Time Frame: 18 months ]
  10. Quality of life (Core 30 Questionnaire) [ Time Frame: Up to 32 months ]
    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"

  11. Quality of life (Lung Cancer 13 Questionnaire) [ Time Frame: Up to 32 months ]
    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".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 with stage IIIB or stage IV disease, who received no 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 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 informed consent
  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


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): NCT03515629


Locations
Layout table for location information
United States, Florida
Regeneron Research Site
Saint Petersburg, Florida, United States, 33709
Italy
Regeneron Research Site
Cremona, Italy, 26100
Lithuania
Regeneron Research Site
Vilnius, Lithuania, 08660
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03515629     History of Changes
Other Study ID Numbers: R2810-ONC-16111
2017-001041-27 ( EudraCT Number )
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Stage IIIB
Stage IV
Non-squamous NSCLC
Squamous NSCLC
Additional relevant MeSH terms:
Layout table for MeSH terms
Cemiplimab
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
Pembrolizumab
Ipilimumab
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents