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Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT03088540
Recruitment Status : Active, not recruiting
First Posted : March 23, 2017
Last Update Posted : October 23, 2023
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:

The primary objectives of the study are:

  • To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells
  • To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells

The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies


Condition or disease Intervention/treatment Phase
Carcinoma，Non-Small-Cell Lung Lung Carcinomas, Non-Small-Cell Non-small-cell Lung Carcinoma Nonsmall Cell Lung Cancer Drug: Pemetrexed Drug: Paclitaxel Drug: Gemcitabine Drug: Cisplatin Drug: Carboplatin Drug: cemiplimab Phase 3

Detailed Description:
There is option to join genomics sub-study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard-of-care chemotherapy

Standard-of-care chemotherapy will administered from these options:

Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance

 Drug: Pemetrexed
Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin

Drug: Paclitaxel
Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin

Drug: Gemcitabine
Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin

Drug: Cisplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.

Drug: Carboplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Experimental: cemiplimab
cemiplimab regimen as monotherapy as per study protocol
 Drug: cemiplimab
Patients will be administered cemiplimab as per protocol.
Other Names:
  • REGN2810
  • Libtayo


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From date of randomization until the date of death, assessed up to 68 months ]
  2. Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1 [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months ]
    PFS as assessed by a blinded IRC using RECIST 1.1.


Secondary Outcome Measures :
  1. Objective response rates (ORR) [ Time Frame: From date of randomization to the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first, up to 68 months ]
    The number of patients with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of patients in the efficacy analysis set

  2. Best overall response (BOR) [ Time Frame: From date of randomization until the date of first documented progression or the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months ]
    The BOR, as determined by the IRC per RECIST 1.1

  3. Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months ]
    Duration of response will be defined as the time between the date of first response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy or death due to any cause, whichever comes first

  4. Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline up to 26 months after treatment ]
  5. Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: Baseline up to 26 months after treatment ]
  6. Incidence of Adverse Events (AEs) [ Time Frame: Baseline up to 68 months after treatment ]
  7. Incidence of serious adverse events (SAEs) [ Time Frame: Baseline up to 68 months after treatment ]
  8. Incidence of deaths [ Time Frame: Baseline up to 68 months after treatment ]
  9. Incidence of laboratory abnormalities [ Time Frame: Baseline up to 68 months after treatment ]
    Number of patients with laboratory abnormalities

  10. Measure concentrations of cemiplimab in serum [ Time Frame: Baseline up to 68 months after treatment ]
    Maximum Plasma Concentration [Cmax]

  11. Characterize the pharmacokinetics (PK) of cemiplimab [ Time Frame: Baseline up to 68 months after treatment ]
    Area Under the Curve [AUC]


Eligibility Criteria
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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.


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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:

A patient must meet the following criteria to be eligible for inclusion in the study:

  1. Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
  2. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
  3. Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
  4. At least 1 radiographically measureable lesion per RECIST 1.1
  5. ECOG performance status of ≤1
  6. Anticipated life expectancy of at least 3 months
  7. Adequate organ and bone marrow function

Key Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

  1. Patients that 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 EGFR gene mutations, ALK gene translocations, or ROS1 fusions
  4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
  5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to randomization
  6. Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
  7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
  8. Another malignancy that is progressing or requires treatment
  9. Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
  10. Active infection requiring systemic therapy within 14 days prior to randomization
  11. Prior therapy with anti-PD 1 or anti-PD L1
  12. Treatment-related immune-mediated AEs from immune-modulatory agents
  13. Receipt of an investigational drug or device within 30 days
  14. Receipt of a live vaccine within 30 days of planned start of study medication
  15. Major surgery or significant traumatic injury within 4 weeks prior to first dose
  16. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
  17. Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
  18. Pregnant or breastfeeding women
  19. Women of childbearing potential or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose

Note: Other protocol defined Inclusion/Exclusion criteria 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): NCT03088540


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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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03088540    
Other Study ID Numbers: R2810-ONC-1624
2016-004407-31 ( EudraCT Number )
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: October 23, 2023
Last Verified: October 2023

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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:
Previous Smoker
Current Smoker
Stage IIIB
 Stage IIIC
Stage IV
PD-L1
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
 Gemcitabine
Pemetrexed
Cemiplimab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Immunological