Clinical Trials /

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE).

NCT02542293

Description:

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Study of 1st Line Therapy Study of MEDI4736 With <span class="go-doc-concept go-doc-intervention">Tremelimumab</span> Versus SoC in Non Small-Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> (<span class="go-doc-concept go-doc-disease">NSCLC</span>) (NEPTUNE).

Title

  • Brief Title: Study of 1st Line Therapy Study of MEDI4736 With Tremelimumab Versus SoC in Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE).
  • Official Title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)
  • Clinical Trial IDs

    NCT ID: NCT02542293

    ORG ID: D419AC00003

    Trial Conditions

    Non Small Cell Lung Carcinoma (NSCLC)

    Trial Interventions

    Drug Synonyms Arms
    Paclitaxel + carboplatin Platinum based Standard of Care Chemotherapy Standard of Care
    Gemcitabine + cisplatin Platinum based Standard of Care Chemotherapy Standard of Care
    Gemcitabine + carboplatin Platinum based Standard of Care Chemotherapy Standard of Care
    Pemetrexed + cisplatin Platinum based Standard of Care Chemotherapy Standard of Care
    Pemetrexed + carboplatin Platinum based Standard of Care Chemotherapy Standard of Care

    Trial Purpose

    This is a randomized, open-label, multi-center, global, Phase III study to determine the
    efficacy and safety of MEDI4736 + tremelimumab combination therapy versus platinum-based SoC
    chemotherapy in the first-line treatment of patients with epidermal growth factor receptor
    (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

    Detailed Description

    Patients will be randomized in a 1:1 to receive treatment with MEDI4736 + tremelimumab
    combination therapy or SoC therapy. The primary objective of this study is to assess the
    efficacy of combination treatment compared with SoC in terms of Overall Survival (OS) in
    patients.

    Trial Arms

    Name Type Description Interventions
    Combination Therapy Experimental PD-L1 monoclonal antibody + Tremelimumab
    Standard of Care Active Comparator Standard of Care chemotherapy treatment Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin, Pemetrexed + carboplatin

    Eligibility Criteria

    Inclusion Criteria:

    For inclusion in the study, patients should fulfill the following criteria:

    - Aged at least 18 years

    - Documented evidence of Stage IV NSCLC

    - No activating EGFR mutation or ALK rearrangement

    - No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC

    - World Health Organization (WHO) Performance Status of 0 or 1

    Exclusion Criteria:

    Patients should not enter the study if any of the following exclusion criteria are
    fulfilled:

    - Mixed smallcell lung cancer and NSCLC histology

    - Brain metastases or spinal cord compression unless asymptomatic, treated and stable
    (not requiring steroids)

    - Prior exposure to IMT, including, but not limited to, other antiCTLA4, antiPD1, anti
    PDL1,or anti PDL2 antibodies, excluding therapeutic anticancer vaccines

    - Active or prior documented inflammatory bowel disease (eg, Crohn's disease,
    ulcerative colitis)

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 130 Years

    Eligible Gender: Both

    Primary Outcome Measures

    To assess the efficacy of MEDI4736 + tremelimumab combintion therapy compared to Standard of Care (SoC) in terms of Overall Survival (OS) in patients with Non-small-cell lung cancer (NSCLC)

    Secondary Outcome Measures

    To assess the efficacy of MEDI4736 +tremelimumab combination therapy compared to SoC in terms of OS in patients with PD-L1-negative NSCLC

    To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Progression-free survival (PFS).

    To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Objective response rate (ORR).

    To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Duration of response (DoR).

    To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Proportion of patients alive at 18 months (OS18).

    To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Proportion of patients alive and progression free at 12 months (APF12).

    To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2).

    To assess the PK paramenters of MEDI4736 + tremelimumab combination therapy by measuring the concentration in blood and non compartmental PK parameters such as peak concentration and trough

    To investigate the immunogenicity of MEDI4736 and tremelimumab by measuring the presence of Anti-drug Antibodies (confirmatory results: positive and negative; titers)

    Trial Keywords

    NSCLC

    PDL1

    MEDI4736

    Tremelimumab

    OS