Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
NCT ID: NCT02542293
Last Updated: 2025-09-16
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
953 participants
INTERVENTIONAL
2015-11-03
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination Therapy
Durvalumab (PD-L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA-4)
Durvalumab +Tremelimumab
Standard of Care
Standard of Care chemotherapy treatment
Paclitaxel + carboplatin
Chemotherapy Agents
Gemcitabine + cisplatin
Chemotherapy Agents
Gemcitabine + carboplatin
Chemotherapy Agents
Pemetrexed + cisplatin
Chemotherapy Agent
Pemetrexed + carboplatin
Chemotherapy Agent
Interventions
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Durvalumab +Tremelimumab
Paclitaxel + carboplatin
Chemotherapy Agents
Gemcitabine + cisplatin
Chemotherapy Agents
Gemcitabine + carboplatin
Chemotherapy Agents
Pemetrexed + cisplatin
Chemotherapy Agent
Pemetrexed + carboplatin
Chemotherapy Agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged at least 18 years
* Documented evidence of Stage IV NSCLC
* No activating EGFR mutation or ALK rearrangement
* No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
* World Health Organization (WHO) Performance Status of 0 or 1
* No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic anticancer vaccines
Exclusion Criteria
* Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment.
* Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Gilberto de Castro
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina da Universidade de São Paulo
Locations
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Research Site
Anaheim, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Louisville, Kentucky, United States
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Florham Park, New Jersey, United States
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Albuquerque, New Mexico, United States
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East Setauket, New York, United States
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Fresh Meadows, New York, United States
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Poughkeepsie, New York, United States
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Stony Brook, New York, United States
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Zanesville, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Berazategui, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Córdoba, , Argentina
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La Rioja, , Argentina
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Rosario, , Argentina
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San Salvador de Jujuy, , Argentina
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Santa Rosa, , Argentina
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Barretos, , Brazil
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Belo Horizonte, , Brazil
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Belo Horizonte, , Brazil
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Fortaleza, , Brazil
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Ijuí, , Brazil
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Itajaí, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Shumen, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Vratsa, , Bulgaria
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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Beijing, , China
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Changchun, , China
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Chongqing, , China
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Guangzhou, , China
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Hangzhou, , China
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Shanghai, , China
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Shanghai, , China
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Ürümqi, , China
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Wuhan, , China
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Wuhan, , China
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Odense C, , Denmark
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Oulu, , Finland
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Tampere, , Finland
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Holargos, Athens, , Greece
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Ioannina, , Greece
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Hong Kong, , Hong Kong
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King's Park, , Hong Kong
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Shatin, , Hong Kong
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Ahmedabad, , India
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Bangalore, , India
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Bangalore, , India
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Chennai, , India
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Gurgaon, , India
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Karamsad, , India
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New Delhi, , India
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Beersheba, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Bunkyō City, , Japan
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Fukushima, , Japan
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Habikino-shi, , Japan
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Hirosaki-shi, , Japan
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Iizuka-shi, , Japan
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Iwakuni-shi, , Japan
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Kanazawa, , Japan
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Kishiwada-shi, , Japan
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Kobe, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Mitaka-shi, , Japan
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Nagaoka-shi, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Saga, , Japan
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Sagamihara-shi, , Japan
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Sakaishi, , Japan
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Sendai, , Japan
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Tokushima, , Japan
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Ube-shi, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Kuala Lumpur, , Malaysia
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Kuantan, , Malaysia
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Kuching, , Malaysia
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Acapulco, , Mexico
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Aguascalientes, , Mexico
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Mérida, , Mexico
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México, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Arequipa, , Peru
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Bellavista, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Baguio City, , Philippines
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Cebu, , Philippines
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Las Piñas, , Philippines
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Manila, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Bydgoszcz, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Mrozy, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wodzisław Śląski, , Poland
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Amadora, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Doha, , Qatar
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Suceava, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Omsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Dammam, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Daegu, , South Korea
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Hwasun-gun, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Eskilstuna, , Sweden
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Linköping, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Chernivtsі, , Ukraine
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Dnipro, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kapitanivka Village, , Ukraine
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Kharkiv Region, , Ukraine
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Kirovohrad, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Liutizh, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Sumy, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Guildford, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
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Nottingham, , United Kingdom
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Taunton, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Cheng Y, Zhou Q, Han B, Fan Y, Shan L, Chang J, Sun S, Fang J, Chen Y, Sun J, Wu G, Mann H, Naicker K, Shire N, Mok T, de Castro G Jr. NEPTUNE China cohort: First-line durvalumab plus tremelimumab in Chinese patients with metastatic non-small-cell lung cancer. Lung Cancer. 2023 Apr;178:87-95. doi: 10.1016/j.lungcan.2023.01.013. Epub 2023 Feb 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2015-002197-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D419AC00003
Identifier Type: -
Identifier Source: org_study_id
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