Clinical Trials /

Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer

NCT03003962

Description:

This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1-high expression

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer
  • Official Title: A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: D419AC00002
  • NCT ID: NCT03003962

Conditions

  • Non Small Cell Lung Carcinoma NSCLC

Interventions

DrugSynonymsArms
Durvalumab (MEDI4736)Durvalumab
Paclitaxel + carboplatinPlatinum based Standard of Care ChemotherapyStandard of Care
Gemcitabine + cisplatinPlatinum based Standard of Care ChemotherapyStandard of Care
Gemcitabine + carboplatinPlatinum based Standard of Care ChemotherapyStandard of Care
Pemetrexed + cisplatinPlatinum based Standard of Care ChemotherapyStandard of Care
Pemetrexed + carboplatinPlatinum based Standard of Care ChemotherapyStandard of Care

Purpose

This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1-high expression

Detailed Description

      Patients will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy).
      The Co-primary objectives of this study are to assess the efficacy of durvalumab compared to
      SoC in terms of PFS (Progression Free Survival) and OS (Overall Survival) in patients with
      NSCLC
    

Trial Arms

NameTypeDescriptionInterventions
DurvalumabExperimentalPD-L1 monoclonal Antibody monotherapy
    Standard of CareActive ComparatorStandard of Care Platinum-Based chemotherapy
    • Paclitaxel + carboplatin
    • Gemcitabine + cisplatin
    • Gemcitabine + carboplatin
    • Pemetrexed + cisplatin
    • Pemetrexed + carboplatin

    Eligibility Criteria

            Inclusion Criteria
    
              -  Aged at least 18 years
    
              -  Documented evidence of Stage IV NSCLC
    
              -  No sensitizing EGFR mutation and ALK rearrangement
    
              -  PD-L1 expression at least 25%
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    
            Exclusion Criteria:
    
              -  Prior chemotherapy or any other systemic therapy for advanced NSCLC
    
              -  Prior exposure to immune-mediated therapy, including, but not limited to, other
                 anti-cytotoxic T- lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell
                 death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies,
                 excluding therapeutic anticancer vaccines
    
              -  Brain metastases or spinal cord compression unless the patient is stable and off
                 steroids for at least 14 days prior to start of study treatment
    
              -  Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
    
              -  Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or
                 Crohn's disease]
          
    Maximum Eligible Age:130 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The efficacy of Durvalumab therapy compared to SoC in terms of progression-free survival (PFS) in patients with NSCLC
    Time Frame:3 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:The efficacy of Durvalumab compared to SoC in terms of Objective response rate (ORR)
    Time Frame:3 years
    Safety Issue:
    Description:
    Measure:The efficacy of Durvalumab compared to SoC in terms of Duration of response (DoR)
    Time Frame:3 years
    Safety Issue:
    Description:
    Measure:The efficacy of Durvalumab compared to SoC in terms of A Proportion of patients alive and progression free at 12 months from randomization (APF12)
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:The efficacy of Durvalumab compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2)
    Time Frame:3 years
    Safety Issue:
    Description:
    Measure:Disease-related symptoms in subjects treated with durvalumab compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LC13)
    Time Frame:3 years
    Safety Issue:
    Description:
    Measure:Health-related quality of life in subjects treated with durvalumab compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
    Time Frame:3 years
    Safety Issue:
    Description:
    Measure:The immunogenicity of durvalumab by measuring the presence of Anti-drug Antibodies
    Time Frame:3 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:AstraZeneca

    Trial Keywords

    • NSCLC
    • PD-L1
    • Durvalumab
    • MEDI4736
    • PFS
    • OS

    Last Updated

    April 27, 2018