Spots Global Cancer Trial Database for Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
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Trial Identification
Brief Title: Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
Official Title: 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).
Study ID: NCT02542293
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Anaheim, California, United States
Research Site, San Diego, California, United States
Research Site, Santa Rosa, California, United States
Research Site, Louisville, Kentucky, United States
Research Site, Florham Park, New Jersey, United States
Research Site, Albuquerque, New Mexico, United States
Research Site, East Setauket, New York, United States
Research Site, Fresh Meadows, New York, United States
Research Site, Poughkeepsie, New York, United States
Research Site, Stony Brook, New York, United States
Research Site, Canton, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Zanesville, Ohio, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Houston, Texas, United States
Research Site, Berazategui, , Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Caba, , Argentina
Research Site, Córdoba, , Argentina
Research Site, La Rioja, , Argentina
Research Site, Rosario, , Argentina
Research Site, San Salvador de Jujuy, , Argentina
Research Site, Santa Rosa, , Argentina
Research Site, Barretos, , Brazil
Research Site, Belo Horizonte, , Brazil
Research Site, Belo Horizonte, , Brazil
Research Site, Fortaleza, , Brazil
Research Site, Ijui, , Brazil
Research Site, Itajai, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São José do Rio Preto, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Plovdiv, , Bulgaria
Research Site, Shumen, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Vratza, , Bulgaria
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Temuco, , Chile
Research Site, Viña del Mar, , Chile
Research Site, Beijing, , China
Research Site, Changchun, , China
Research Site, Chongqing, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Urumqi, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Odense C, , Denmark
Research Site, Oulu, , Finland
Research Site, Tampere, , Finland
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Heraklion, , Greece
Research Site, Holargos, Athens, , Greece
Research Site, Ioannina, , Greece
Research Site, Hong Kong, , Hong Kong
Research Site, King's Park, , Hong Kong
Research Site, Shatin, , Hong Kong
Research Site, Ahmedabad, , India
Research Site, Bangalore, , India
Research Site, Bangalore, , India
Research Site, Chennai, , India
Research Site, Gurgaon, , India
Research Site, Karamsad, , India
Research Site, New Delhi, , India
Research Site, Beer Sheva, , Israel
Research Site, Jerusalem, , Israel
Research Site, Kfar Saba, , Israel
Research Site, Nahariya, , Israel
Research Site, Petah Tikva, , Israel
Research Site, Ramat Gan, , Israel
Research Site, Bunkyo-ku, , Japan
Research Site, Fukushima-shi, , Japan
Research Site, Habikino-shi, , Japan
Research Site, Hirosaki-shi, , Japan
Research Site, Iizuka-shi, , Japan
Research Site, Iwakuni-shi, , Japan
Research Site, Kanazawa, , Japan
Research Site, Kishiwada-shi, , Japan
Research Site, Kobe-shi, , Japan
Research Site, Kurume-shi, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Mitaka-shi, , Japan
Research Site, Nagaoka-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Niigata-shi, , Japan
Research Site, Okayama-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Saga-shi, , Japan
Research Site, Sagamihara-shi, , Japan
Research Site, Sakai-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Tokushima-shi, , Japan
Research Site, Ube-shi, , Japan
Research Site, Wakayama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Daegu, , Korea, Republic of
Research Site, Hwasun-gun, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Kuala Lumpur, , Malaysia
Research Site, Kuantan, , Malaysia
Research Site, Kuching, , Malaysia
Research Site, Acapulco, , Mexico
Research Site, Aguascalientes, , Mexico
Research Site, Mexico, , Mexico
Research Site, Monterrey, , Mexico
Research Site, Mérida, , Mexico
Research Site, México, , Mexico
Research Site, Arequipa, , Peru
Research Site, Bellavista, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Baguio City, , Philippines
Research Site, Cebu, , Philippines
Research Site, Las Pinas City, , Philippines
Research Site, Manila, , Philippines
Research Site, Manila, , Philippines
Research Site, Quezon City, , Philippines
Research Site, Bydgoszcz, , Poland
Research Site, Kielce, , Poland
Research Site, Kraków, , Poland
Research Site, Mrozy, , Poland
Research Site, Olsztyn, , Poland
Research Site, Poznan, , Poland
Research Site, Poznań, , Poland
Research Site, Warszawa, , Poland
Research Site, Warszawa, , Poland
Research Site, Wodzisław Śląski, , Poland
Research Site, Łódź, , Poland
Research Site, Amadora, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Porto, , Portugal
Research Site, Porto, , Portugal
Research Site, Doha, , Qatar
Research Site, Suceava, , Romania
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Omsk, , 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, St. Petersburg, , Russian Federation
Research Site, Dammam, , Saudi Arabia
Research Site, Riyadh, , Saudi Arabia
Research Site, Riyadh, , Saudi Arabia
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Eskilstuna, , Sweden
Research Site, Linköping, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Uppsala, , Sweden
Research Site, Adana, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Chernivtsі, , Ukraine
Research Site, Dnipro, , Ukraine
Research Site, Ivano-Frankivsk, , Ukraine
Research Site, Kapitanivka Village, , Ukraine
Research Site, Kharkiv Region, , Ukraine
Research Site, Kirovohrad, , Ukraine
Research Site, Kyiv, , Ukraine
Research Site, Kyiv, , Ukraine
Research Site, Lviv, , Ukraine
Research Site, Lyutizh, , Ukraine
Research Site, Odesa, , Ukraine
Research Site, Sumy, , Ukraine
Research Site, Uzhhorod, , Ukraine
Research Site, Vinnytsia, , Ukraine
Research Site, Guildford, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Nottingham, , United Kingdom
Research Site, Taunton, , United Kingdom
Research Site, Wirral, , United Kingdom
Research Site, Wolverhampton, , United Kingdom
Contact Details
Name: Gilberto de Castro
Affiliation: Faculdade de Medicina da Universidade de São Paulo
Role: PRINCIPAL_INVESTIGATOR
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