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)(MYSTIC).
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)(MYSTIC).
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
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.
Inclusion Criteria:
For inclusion in the study, patients should fulfill the following criteria:
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
Saint Catherines, Ontario L2R 6P9, Canada
Homburg/Saar, 66421, Germany
Himeji-shi, 670-8520, Japan
Hirakata-shi, 573-1191, Japan
Hirosaki-shi, 036-8545, Japan
Iizuka-shi, 820-8505, Japan
Iwakuni-shi, 740-8510, Japan
Izumi-shi, 594-0073, Japan
Kishiwada-shi, 596-8501, Japan
Koga-shi, 811-3195, Japan
Mitaka-shi, 181-8611, Japan
Nagaoka-shi, 940-2085, Japan
Saitama-shi, 336-8522, Japan
Shinjuku-ku, 162-8655, Japan
Ube-shi, 755-0241, Japan
Yokosuka-shi, 238-8558, Japan
Changwon-si, 51353, South Korea