Clinical Trials /

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

NCT03088540

Description:

To assess the safety and efficacy of cemiplimab as first-line treatment in patients with advanced or metastatic NSCLC whose tumors express PD-L1.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-1624
  • SECONDARY ID: 2016-004407-31
  • NCT ID: NCT03088540

Conditions

  • Carcinoma,Non-Small-Cell Lung
  • Lung Carcinomas, Non-Small-Cell
  • Non-small-cell Lung Carcinoma
  • Nonsmall Cell Lung Cancer

Interventions

DrugSynonymsArms
PemetrexedStandard-of-care chemotherapy
PaclitaxelStandard-of-care chemotherapy
GemcitabineStandard-of-care chemotherapy
CisplatinStandard-of-care chemotherapy
CarboplatinStandard-of-care chemotherapy
REGN2810REGN2810

Purpose

To assess the safety and efficacy of REGN2810 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.
    

Trial Arms

NameTypeDescriptionInterventions
Standard-of-care chemotherapyActive ComparatorStandard-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
  • Pemetrexed
  • Paclitaxel
  • Gemcitabine
  • Cisplatin
  • Carboplatin
REGN2810ExperimentalREGN2810 regimen as monotherapy as per study protocol
  • REGN2810

Eligibility Criteria

        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 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

        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 informed
             consent

          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

          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. Known active hepatitis B (positive result) or hepatitis C (known positive result) and
             known quantitative HCV RNA results greater than the lower limits of detection of the
             assay)

         10. Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency
             syndrome indicating uncontrolled active infection. Patients on highly active
             antiretroviral therapy with undetectable RNA levels and CD4 counts above 350 are
             permitted

         11. Active infection requiring systemic therapy within 14 days prior to randomization

         12. Prior therapy with anti-PD 1 or anti-PD L1

         13. Treatment-related immune-mediated AEs from immune-modulatory agents

         14. Receipt of an investigational drug or device within 30 days

         15. Receipt of a live vaccine within 30 days of planned start of study medication

         16. Major surgery or significant traumatic injury within 4 weeks prior to first dose

         17. Documented allergic or acute hypersensitivity reaction attributed to antibody
             treatments

         18. Known allergy to doxycycline or other tetracycline antibiotics

         19. Known psychiatric or substance abuse disorder that would interfere with participation
             with the requirements of the study, including current use of any illicit drugs

         20. Pregnant or breastfeeding women

         21. 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

         22. Patients who are committed to an institution by virtue of an order issued either by
             the judicial or the administrative authorities will be excluded from this study
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:PFS as assessed by a blinded IRC using RECIST 1.1.

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:From date of randomization until date of death, assessed up to 39 months
Safety Issue:
Description:Overall survival will be defined as the time from randomization to the date of death.
Measure: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
Safety Issue:
Description: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
Measure: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
Safety Issue:
Description:The BOR, as determined by the IRC per RECIST 1.1
Measure: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
Safety Issue:
Description: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
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:Baseline up to 12 months after treatment
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Baseline up to 12 months after treatment
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Baseline up to 12 months after treatment
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Baseline up to 12 months after treatment
Safety Issue:
Description:Number of patients with laboratory abnormalities
Measure:Measure concentrations of REGN2810 in serum
Time Frame:Baseline up to 12 months after treatment
Safety Issue:
Description:Maximum Plasma Concentration [Cmax]
Measure:Characterize the pharmacokinetics (PK) of REGN2810
Time Frame:Baseline up to 12 months after treatment
Safety Issue:
Description:Area Under the Curve [AUC]

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

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