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).

Official Title

A Phase III Randomized, Open-Label, Multi-Centre, 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) (MYSTIC)

Summary:

This is a randomized, open-label, multi-centre, 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

Trial Description

Primary Outcome:

  • The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of progression-free survival (PFS) and Overall Survival (OS) in patients with NSCLC
Secondary Outcome:
  • 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 (EORTC QLQ-C30)and QLQ-LC13
  • 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 monotherapy compared to SoC in terms of Objective Response Rate (ORR)
  • 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).
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 objectives of this study are: • To assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of PFS (Progression Free Survival) and OS (Overall Survival) in patients with NSCLC

View this trial on ClinicalTrials.gov

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Resources

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