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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 : Recruiting
First Posted : March 23, 2017
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 3, 2017
First Posted Date  ICMJE March 23, 2017
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE May 29, 2017
Estimated Primary Completion Date February 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
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 30 months ]
PFS as assessed by a blinded IRC using RECIST 1.1.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03088540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Overall survival (OS) [ Time Frame: From date of randomization until date of death, assessed up to 39 months ]
    Overall survival will be defined as the time from randomization to the date of death.
  • 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 30 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
  • Best overall response (BOR) [ 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 30 months ]
    The BOR, as determined by the IRC per RECIST 1.1
  • 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 30 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
  • Assess quality of life (QOL) of patients treated with cemiplimab versus patients receiving platinum-based chemotherapies as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline up to 30 days after treatment ]
  • Change From Baseline in Quality of Life as measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: Baseline up to 30 days after treatment ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of deaths [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of laboratory abnormalities [ Time Frame: Baseline up to 12 months after treatment ]
    Number of patients with laboratory abnormalities
  • Measure concentrations of cemiplimab in serum [ Time Frame: Baseline up to 12 months after treatment ]
    Maximum Plasma Concentration [Cmax]
  • Characterize the pharmacokinetics (PK) of cemiplimab [ Time Frame: Baseline up to 12 months after treatment ]
    Area Under the Curve [AUC]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • Overall survival (OS) [ Time Frame: From date of randomization until date of death, assessed up to 39 months ]
    Overall survival will be defined as the time from randomization to the date of death.
  • 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 30 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
  • Best overall response (BOR) [ 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 30 months ]
    The BOR, as determined by the IRC per RECIST 1.1
  • Compare the duration of response (DOR) of REGN2810 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 30 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
  • Assess quality of life (QOL) of patients treated with REGN2810 versus patients receiving platinum-based chemotherapies as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline up to 30 days after treatment ]
  • Change From Baseline in Quality of Life as measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: Baseline up to 30 days after treatment ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of deaths [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of laboratory abnormalities [ Time Frame: Baseline up to 12 months after treatment ]
    Number of patients with laboratory abnormalities
  • Measure concentrations of REGN2810 in serum [ Time Frame: Baseline up to 12 months after treatment ]
    Maximum Plasma Concentration [Cmax]
  • Characterize the pharmacokinetics (PK) of REGN2810 [ Time Frame: Baseline up to 12 months after treatment ]
    Area Under the Curve [AUC]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE 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
Brief Summary To assess the safety and efficacy of cemiplimab as first-line treatment in patients with advanced or metastatic NSCLC whose tumors express PD-L1.
Detailed Description There is option to join genomics sub-study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma,Non-Small-Cell Lung
  • Lung Carcinomas, Non-Small-Cell
  • Non-small-cell Lung Carcinoma
  • Nonsmall Cell Lung Cancer
Intervention  ICMJE
  • 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.
  • Drug: cemiplimab
    Patients will be administered cemiplimab as per protocol.
    Other Name: REGN2810
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Pemetrexed
    • Drug: Paclitaxel
    • Drug: Gemcitabine
    • Drug: Cisplatin
    • Drug: Carboplatin
  • Experimental: cemiplimab
    cemiplimab regimen as monotherapy as per study protocol
    Intervention: Drug: cemiplimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
700
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2017)
300
Estimated Study Completion Date  ICMJE February 15, 2023
Estimated Primary Completion Date February 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 who are unwilling to practice highly effective contraception prior to the initial dose, during the study, and for at least 6 months after the last dose

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE Australia,   Belarus,   Brazil,   Bulgaria,   Chile,   Colombia,   Czechia,   Georgia,   Greece,   Hungary,   Jordan,   Lebanon,   Malaysia,   Mexico,   Philippines,   Poland,   Romania,   Russian Federation,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03088540
Other Study ID Numbers  ICMJE R2810-ONC-1624
2016-004407-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP