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 durvalumab + tremelimumab combination therapy compared to SoC in terms of Progression-Free Survival (PFS) and Overall Survival (OS) in patients with NSCLC
  • The efficacy of durvalumab therapy compared to SoC in terms of Overall Survival (OS) in patients with NSCLC
Secondary Outcome:
  • The efficacy of durvalumab monotherapy compared to SoC in terms of Objective Response Rate (ORR) or Progression-Free Survival (PFS)
  • The efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Objective Response Rate (ORR)
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society