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Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy 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: NCT03409614
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : April 25, 2024
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:

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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Part 1: Open label Part 2: Double blind
Primary Purpose: Treatment
Official Title: A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : February 3, 2025
Estimated Study Completion Date : February 3, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Chemo
Part 1: Chemotherapy
 Other: Chemotherapy
Platinum-based doublet chemotherapy Part 1

Drug: Placebo
Matching placebo Part 2
Experimental: REGN2810+Chemo Part 1
Part 1: REGN2810+chemo
 Drug: REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
Other Name: cemiplimab
Experimental: REGN2810+AbbrevChemo+ipi
Part 1: REGN2810+abbrev chemo+ipi
 Drug: REGN2810/chemo/ipi
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
Other Name: cemiplimab
Experimental: Placebo+Chemo
Part 2: Placebo plus chemo
 Drug: Placebo
Matching placebo Part 2
Experimental: REGN2810+Chemo Part 2
Part 2: REGN2810+chemo
 Drug: REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
Other Name: cemiplimab


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 32 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to 32 months ]
  2. Objective response rate [ Time Frame: Up to 32 months ]
  3. Duration of Response (DOR) [ Time Frame: Up to 32 months ]
  4. Best overall response (BOR) [ Time Frame: Up to 32 months ]
  5. Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 32 months ]
  6. Incidence of Dose-limiting toxicities (DLTs) [ Time Frame: Up to 32 months ]
    Part 1 only

  7. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 32 months ]
  8. Incidence of deaths [ Time Frame: Up to 32 months ]
  9. Incidence of laboratory abnormalities [ Time Frame: Up to 32 months ]
  10. Overall survival rate [ Time Frame: 12 months ]
  11. Overall survival rate [ Time Frame: 18 months ]
  12. Overall survival rate [ Time Frame: 24 months ]
  13. Quality of life as measured by EORTC QLQ-C30 [ Time Frame: Up to 32 months ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  14. Quality of life as measured by EORTC QLQ-LC13 [ Time Frame: Up to 32 months ]
    Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)


Eligibility Criteria
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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. Men and women ≥20 years of age for Japanese patients
  2. 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
  3. 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
  4. Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory
  5. At least 1 radiographically measurable 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
  6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  7. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

  1. Part 1 only: 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. 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

Contacts and Locations
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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): NCT03409614


Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03409614    
Other Study ID Numbers: R2810-ONC-16113
2017-001311-36 ( EudraCT Number )
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024

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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:
Stage IIIB
Stage IIIC
Stage IV
Non-squamous NSCLC
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
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents