Clinical Trials /

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

NCT03088540

Description:

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

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

Active, not 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
cemiplimabREGN2810, Libtayocemiplimab

Purpose

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

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
cemiplimabExperimentalcemiplimab regimen as monotherapy as per study protocol
  • cemiplimab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS)
Time Frame:From date of randomization until the date of death, assessed up to 68 months
Safety Issue:
Description:PFS as assessed by a blinded IRC using RECIST 1.1.

Secondary Outcome Measures

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 68 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 the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months
Safety Issue:
Description:The BOR, as determined by the IRC per RECIST 1.1
Measure: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
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: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:Baseline up to 68 months after treatment
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Baseline up to 68 months after treatment
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Baseline up to 68 months after treatment
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Baseline up to 68 months after treatment
Safety Issue:
Description:Number of patients with laboratory abnormalities
Measure:Measure concentrations of cemiplimab in serum
Time Frame:Baseline up to 68 months after treatment
Safety Issue:
Description:Maximum Plasma Concentration [Cmax]
Measure:Characterize the pharmacokinetics (PK) of cemiplimab
Time Frame:Baseline up to 68 months after treatment
Safety Issue:
Description:Area Under the Curve [AUC]

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • Previous Smoker
  • Current Smoker
  • Stage IIIB
  • Stage IIIC
  • Stage IV
  • PD-L1

Last Updated

August 17, 2021