Clinical Trials /

Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033)

NCT02864394

Description:

The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) positive tumors who have experienced disease progression after platinum-containing systemic therapy. The primary hypothesis of this study is that pembrolizumab (MK-3475) prolongs overall survival (OS) and progression-free survival (PFS) compared to docetaxel in participants with PD-L1 positive tumors

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033)
  • Official Title: A Multinational, Multicenter, Phase III, Randomized Open-label Trial of Pembrolizumab Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 3475-033
  • SECONDARY ID: MK-3475-033
  • NCT ID: NCT02864394

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
pembrolizumab 2 mg/kgKEYTRUDA®, MK-3475Pembrolizumab (MK-3475) 2mg/kg
Docetaxel 75 mg/m^2TAXOTERE®Docetaxel 75 mg/m^2

Purpose

The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) positive tumors who have experienced disease progression after platinum-containing systemic therapy. The primary hypothesis of this study is that pembrolizumab (MK-3475) prolongs overall survival (OS) and progression-free survival (PFS) compared to docetaxel in participants with PD-L1 positive tumors

Trial Arms

NameTypeDescriptionInterventions
Pembrolizumab (MK-3475) 2mg/kgExperimentalParticipants with NSCLC receive pembrolizumab 2mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 35 doses (approximately 24 months). Participants who attain a confirmed complete response (CR) per Response Criteria in Solid Tumor Version 1.1 (RECIST 1.1) or those that stop trial therapy after 35 treatment administrations for reasons other than disease progression or intolerability may be eligible for re-treatment with open-label pembrolizumab as monotherapy after they have experienced radiographic disease progression for up to 17 doses (approximately an additional 12 months).
    Docetaxel 75 mg/m^2ExperimentalParticipants with NSCLC receive Docetaxel 75 mg/m^2 IV over 1 hour Q3W until disease progression, toxicity, investigator's decision to discontinue or consent withdrawal
    • Docetaxel 75 mg/m^2

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Chinese participants must be born, raised, and reside in China
    
              -  Has a histologically or cytologically confirmed diagnosis of stage IIIB/IV or
                 recurrent NSCLC and have at least one measurable lesion as defined by RECIST 1.1
    
              -  Has a life expectancy of at ≥3 months
    
              -  Has progression of disease (investigator determined) per RECIST 1.1 after treatment
                 with at least two cycles of a platinum-containing doublet
    
              -  Has documentation of epidermal growth factor receptor (EGRF) mutation and anaplastic
                 lymphoma kinase (ALK) translocation status
    
              -  Participants with an EGFR sensitizing mutation tumor will be excluded
    
              -  Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 10
                 days prior to study start
    
              -  Has provided archival tumor tissue sample or newly obtained formalin fixed tumor
                 tissue from a recent biopsy of a tumor lesion not previously irradiated
    
              -  Has a PD-L1 positive tumor as determined by immunohistochemistry at a central
                 laboratory
    
              -  Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or
                 less (except alopecia)
    
              -  Has recovered from the toxicity and/or complications of any recent major surgery or
                 radiation therapy
    
              -  Females must not be pregnant (negative urine or serum human chorionic gonadotropin
                 test within 72 hours prior to receiving the first dose of study medication)
    
              -  Female and male participants of reproductive potential must agree to use adequate
                 contraception starting with the first dose of study therapy through 120 days after the
                 last dose of study therapy
    
            Exclusion Criteria:
    
              -  Has received prior therapy with docetaxel for NSCLC
    
              -  Is currently participating or has participated in a study of an investigational agent
                 or using an investigational device within 4 weeks of the first dose of study treatment
    
              -  Is receiving systemic steroid therapy within 3 days prior to the first dose of study
                 treatment or receiving any other form of immunosuppressive
    
              -  Is expected to require any other form of systemic or localized antineoplastic therapy
                 while on study including maintenance therapy with another agent for NSCLC or radiation
                 therapy
    
              -  Has received prior systemic cytotoxic chemotherapy, antineoplastic biological therapy
                 (e.g., cetuximab), any other agents used as systemic treatment for cancer, or major
                 surgery within 3 weeks of the first dose of study treatment; received thoracic
                 radiation therapy of > 30 Gray Units (Gy) within 6 months of the first dose of study
                 treatment; received prior ALK-directed tyrosine kinase inhibitor therapy or completed
                 palliative radiotherapy of 30 Gy or less within 7 days of the first dose of study
                 treatment
    
              -  Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1),
                 anti-PD-L1, anti-PD-L2, with an agent directed to an agonist or antagonist T-cell
                 check point receptor, or if the subject has previously participated in Merck sponsored
                 clinical trials evaluating pembrolizumab (MK-3475)
    
              -  Has a known additional malignancy that is progressing or requires active treatment,
                 with the exception of early stage cancers, treated with curative intent, basal cell
                 carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer,
                 or in situ breast cancer that has undergone potentially curative therapy
    
              -  Has known active central nervous system metastases and/or carcinomatous meningitis
    
              -  Has active autoimmune disease that has required systemic treatment in past 2 years
    
              -  Has had an allogeneic tissue/solid organ transplant
    
              -  Has a history of (non-infectious) pneumonitis that required steroids or current
                 pneumonitis
    
              -  Has received or will receive a live vaccine within 30 days prior to the first
                 administration of study medication
    
              -  Has an active infection requiring intravenous systemic therapy
    
              -  Has known history of Human Immunodeficiency Virus (HIV) (HIV ½ antibodies)
    
              -  Has known active Hepatitis B or C
    
              -  Has known psychiatric or substance abuse disorders that would interfere with
                 cooperation with the requirements of the trial
    
              -  Is, at the time of signing informed consent, a regular user (including "recreational
                 use") of any illicit drugs or had a recent history (within the last year) of substance
                 abuse (including alcohol)
    
              -  Is pregnant or breastfeeding, or expecting to conceive or father children starting
                 with the screening visit (Visit 1) through 120 days after the last dose of
                 pembrolizumab (MK-3475) or 180 days after the last dose of docetaxel
    
              -  Requires treatment with a strong inhibitor of Cytochrome P450 3A4
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:OS in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score 1 to 49%)
    Time Frame:From time of screening until end of follow-up (Up to 26 months)
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score 1 to 49%)
    Time Frame:From time of screening until end of follow-up (Up to 26 months)
    Safety Issue:
    Description:
    Measure:DOR per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score ≥50%)
    Time Frame:From time of screening until end of follow-up (Up to 26 months)
    Safety Issue:
    Description:
    Measure:Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score 1 to 49%)
    Time Frame:From time of screening until end of follow-up (Up to 26 months)
    Safety Issue:
    Description:
    Measure:ORR per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score ≥50%)
    Time Frame:From time of screening until end of follow-up (Up to 26 months)
    Safety Issue:
    Description:
    Measure:Number of Participants Who Experience an Adverse Event (AE)
    Time Frame:From time of first dose until the end of follow-up (up to 39 months)
    Safety Issue:
    Description:
    Measure:Number of Participants Who Discontinue Study Drug Due to an AE
    Time Frame:From time of first dose until the end of study drug (up to 36 months)
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Merck Sharp & Dohme Corp.

    Last Updated

    April 3, 2018