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Brief Title: Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
Official Title: A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer
Study ID: NCT03003962
Brief Summary: This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1 high expression (PEARL)
Detailed Description: Patients with stage IV NSCLC will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy). The dual primary objectives of this study are to assess the efficacy of durvalumab versus SoC in terms of OS (Overall Survival) in all randomized patients and in patients who are at low risk of EM (early mortality)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Anaheim, California, United States
Research Site, Box Hill, , Australia
Research Site, Gosford, , Australia
Research Site, Kogarah, , Australia
Research Site, St Leonards, , Australia
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Bengbu, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Haikou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Jinan, , China
Research Site, Linhai, , China
Research Site, Nanchang, , China
Research Site, Nanjing, , China
Research Site, Ningbo, , China
Research Site, Shanghai, , China
Research Site, Shenyang, , China
Research Site, Shijiazhuang, , China
Research Site, Urumqi, , China
Research Site, Urumqi, , China
Research Site, Wanzhou, , China
Research Site, Wenzhou, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Xi'an, , China
Research Site, Zhengzhou, , China
Research Site, Zhuhai, , China
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Deszk, , Hungary
Research Site, Farkasgyepü, , Hungary
Research Site, Gyöngyös - Mátraháza, , Hungary
Research Site, Székesfehérvár, , Hungary
Research Site, Törökbálint, , Hungary
Research Site, Changwon-si, , Korea, Republic of
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Incheon, , Korea, Republic of
Research Site, Jinju-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon-si, , Korea, Republic of
Research Site, Almelo, , Netherlands
Research Site, Bialystok, , Poland
Research Site, Grudziądz, , Poland
Research Site, Koszalin, , Poland
Research Site, Lublin, , Poland
Research Site, Mrozy, , Poland
Research Site, Warszawa, , Poland
Research Site, Wroclaw, , Poland
Research Site, Arkhangelsk, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Omsk, , Russian Federation
Research Site, Rostov-on-Don, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Sankt-Peterburg, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Research Site, Volgograd, , Russian Federation
Research Site, Taichung City, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Muang, , Thailand
Research Site, Songkla, , Thailand
Research Site, Ankara, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Malatya, , Turkey
Research Site, Pamukkale, , Turkey
Research Site, Can Tho, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Research Site, Ho Chi Minh, , Vietnam