Clinical Trials /

Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC).

NCT02453282

Description:

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy 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 locally advanced or metastatic NSCLC

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

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02453282

Trial Eligibility

Document

Phase III Open Label First Line Therapy Study of MEDI 4736 With or Without <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>).

Title

  • Brief Title: Phase III Open Label First Line Therapy Study of MEDI 4736 With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC).
  • Official Title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy 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: NCT02453282

    ORG ID: D419AC00001

    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 and MEDI4736 monotherapy
    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 1:1:1 ratio to receive treatment with MEDI4736 +
    tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.
    The primary objective of this study is to assess the efficacy of combination or monotherapy
    treatment compared with SoC in terms of Progression Free Survival (PFS) in patients.

    Trial Arms

    Name Type Description Interventions
    Monotherapy Experimental PD-L1 monoclonal Antibody monotherapy.
    Combination Therapy Experimental PD-L1+Tremelimumab combination therapy
    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 small-cell lung cancer and NSCLC histology or not otherwise specified (NSCLC
    NOS)

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

    - Prior exposure to Immunomodulatory therapy (IMT), 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

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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of progression-free survival (PFS) in patients with NSCLC

    Secondary Outcome Measures

    The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of progression-free survival (PFS)

    The efficacy of MEDI4736 monotherapy compared to SoC in terms of progression free survival (PFS)

    Health related quality of life (HRQoL) in patients treated with MEDI4736 + tremelimumab or MEDI4736 compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30)

    The pharmacokinetics (PK) of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy

    The immunogenicity of MEDI4736 and tremelimumab

    The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Objective Response Rate (ORR)

    The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Duration of Response (DoR)

    The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of alive and progression free at 12 months (APF12)

    The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of time from randomization to second progression (PFS2)

    The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Overall Survival (OS)

    The efficacy of MEDI4736 monotherapy compared to SoC in terms of Objective Response Rate (ORR)

    The efficacy of MEDI4736 monotherapy compared to SoC in terms of time from randomization to second progression (PFS2)

    The efficacy of MEDI4736 monotherapy compared to SoC in terms of Overall Survival (OS)

    Disease-related symptoms and HRQoL in patients treated with MEDI4736 + tremelimumab or MEDI4736 compared to SoC using the European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire - Lung Cancer 13 items (EORTC QLQ-LC13).

    Trial Keywords

    NSCLC, PD-L1, MEDI4736, Tremelimumab, PFS