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).
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).
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.
Patients will be randomized in a 1:1 to receive treatment with durvalumab + 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.
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:
CABA, C1426ANZ, Argentina
Ciudad de Buenos Aires, C1025ABI, Argentina
Holargos, Athens, 155 62, Greece
King's Park, 150001, Hong Kong
Habikino-shi, 583-8588, Japan
Hirosaki-shi, 036-8545, Japan
Iizuka-shi, 820-8505, Japan
Iwakuni-shi, 740-8510, Japan
Kishiwada-shi, 596-8501, Japan
Kurume-shi, 830-0011, Japan
Mitaka-shi, 181-8611, Japan
Nagaoka-shi, 940-2085, Japan
Sagamihara-shi, 252-0375, Japan
Ube-shi, 755-0241, Japan
Hwasun-gun, 58128, South Korea
Chernivtsі, 58013, Ukraine
Kapitanivka Village, 08111, Ukraine
Kharkiv Region, 61070, Ukraine