Клинические исследование Non-Small Cell Lung Cancer: Durvalumab, Placebo, Carboplatin/Paclitaxel, Cisplatin/Gemcitabine, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin

Спонсоры	Ведущий спонсор: AstraZeneca
Источник	AstraZeneca
Краткое содержание	This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Общий статус

Recruiting

Дата начала

2018-12-06

Дата завершения

2024-04-30

Дата первичного завершения

2024-04-30

Фаза

Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Pathological Complete Response (pCR) in modified intent-to-treat (mITT)	From screening pathology to an average of 15 weeks after first dose.
Event-Free Survival (EFS)	Up to 5.5 years after first patient randomized.

Вторичный результат

Мера	Временное ограничение
Disease-free survival (DFS) in modified resected population	From date of randomization to 5.5 years after date of resection
Major Pathological Response (mPR)	From screening pathology to an average of 15 weeks after first dose.
Overall Survival (OS)	From date of randomization to 5.5 years after randomization
Event-free survival (EFS) in PD-L1-TC ≥1% positive patients	From date of randomization to 5.5 years after randomization
pCR in PD-L1-TC ≥1% positive patients	From screening pathology to an average of 15 weeks after first dose
Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients	From date of randomization to 5.5 years after date of resection
Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients	From screening pathology to an average of 15 weeks after first dose.
Overall Survival (OS) in PD-L1-TC ≥1% positive patients	From date of randomization to 5.5 years after randomization.
To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery	From date of screening to 6 months after last dose of IP
To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery	From date of screening to 6 months after last dose of IP
To assess the PK of durvalumab in blood (through concentration)	From date of randomization to 2 months after resection
Presence of ADA for durvalumab	From date of randomization to 3 months after last dose of IP

Регистрация

800

Состояние	Non-Small Cell Lung Cancer
Вмешательство	Тип вмешательства: Drug Название вмешательства: Durvalumab Описание: Durvalumab IV (intravenous infusion) Этикетка Arm Group: Arm 1: Durvalumab + platinum-based chemotherapy Другое имя: MEDI4736 Тип вмешательства: Other Название вмешательства: Placebo Описание: Placebo IV (intravenous infusion) Этикетка Arm Group: Arm 2: Placebo + platinum-based chemotherapy Тип вмешательства: Drug Название вмешательства: Carboplatin/Paclitaxel Описание: Carboplatin/Paclitaxel, as per standard of care Тип вмешательства: Drug Название вмешательства: Cisplatin/Gemcitabine Описание: Cisplatin/Gemcitabine, as per standard of care Тип вмешательства: Drug Название вмешательства: Pemetrexed/Cisplatin Описание: Pemetrexed/Cisplatin, as per standard of care Тип вмешательства: Drug Название вмешательства: Pemetrexed/Carboplatin Описание: Pemetrexed/Carboplatin, as per standard of care
Приемлемость	Критерии: Inclusion Criteria: - Age ≥18 years - Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease - World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment - At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline - No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines - Adequate organ and marrow function - Confirmation of a patient's tumour PD-L1 status - Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status - Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy Exclusion Criteria: - History of allogeneic organ transplantation - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome) - History of another primary malignancy - History of active primary immunodeficiency - Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus - Deemed unresectable NSCLC by multidisciplinary evaluation - Patients who have pre-operative radiotherapy treatment as part of their care plan - Patients who have brain metastases or spinal cord compression - Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC - Known allergy or hypersensitivity to any of the study drugs or excipients - Existence of more than one primary tumour such as mixed small cell and NSCLC histology - Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections - Patients with a documented test result confirming the presence of EGFRm or ALK translocation Пол: All Минимальный возраст: 18 Years Максимальный возраст: 120 Years Здоровые волонтеры: No

Состояние

Non-Small Cell Lung Cancer

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Durvalumab

Описание: Durvalumab IV (intravenous infusion)

Этикетка Arm Group: Arm 1: Durvalumab + platinum-based chemotherapy

Другое имя: MEDI4736

Тип вмешательства: Other

Название вмешательства: Placebo

Описание: Placebo IV (intravenous infusion)

Этикетка Arm Group: Arm 2: Placebo + platinum-based chemotherapy

Тип вмешательства: Drug

Название вмешательства: Carboplatin/Paclitaxel

Описание: Carboplatin/Paclitaxel, as per standard of care

Тип вмешательства: Drug

Название вмешательства: Cisplatin/Gemcitabine

Описание: Cisplatin/Gemcitabine, as per standard of care

Тип вмешательства: Drug

Название вмешательства: Pemetrexed/Cisplatin

Описание: Pemetrexed/Cisplatin, as per standard of care

Тип вмешательства: Drug

Название вмешательства: Pemetrexed/Carboplatin

Описание: Pemetrexed/Carboplatin, as per standard of care

Приемлемость

Критерии:

Inclusion Criteria: - Age ≥18 years - Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease - World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment - At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline - No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines - Adequate organ and marrow function - Confirmation of a patient's tumour PD-L1 status - Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status - Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy Exclusion Criteria: - History of allogeneic organ transplantation - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome) - History of another primary malignancy - History of active primary immunodeficiency - Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus - Deemed unresectable NSCLC by multidisciplinary evaluation - Patients who have pre-operative radiotherapy treatment as part of their care plan - Patients who have brain metastases or spinal cord compression - Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC - Known allergy or hypersensitivity to any of the study drugs or excipients - Existence of more than one primary tumour such as mixed small cell and NSCLC histology - Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections - Patients with a documented test result confirming the presence of EGFRm or ALK translocation

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

120 Years

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
John Heymach, MD	Principal Investigator	UT MD Anderson Cancer Institute

Общий контакт

Фамилия: AstraZeneca Clinical Study Information Center

Телефон: 1-877-240-9479

Расположение

Объект:	Положение дел:
Research Site \| Phoenix, Arizona, 85054, United States	Recruiting
Research Site \| Duarte, California, 91010, United States	Recruiting
Research Site \| Long Beach, California, 90806, United States	Withdrawn
Research Site \| Orange, California, 92868, United States	Terminated
Research Site \| Aurora, Colorado, 80012, United States	Not yet recruiting
Research Site \| Boca Raton, Florida, 33486-2305, United States	Terminated
Research Site \| Jacksonville, Florida, 32256, United States	Recruiting
Research Site \| Tampa, Florida, 33612, United States	Withdrawn
Research Site \| Chicago, Illinois, 60612, United States	Recruiting
Research Site \| Wichita, Kansas, 67214, United States	Recruiting
Research Site \| Ashland, Kentucky, 41101, United States	Recruiting
Research Site \| Lexington, Kentucky, 40513, United States	Recruiting
Research Site \| Baltimore, Maryland, 21204, United States	Recruiting
Research Site \| Silver Spring, Maryland, 20910, United States	Recruiting
Research Site \| Detroit, Michigan, 48201, United States	Withdrawn
Research Site \| Duluth, Minnesota, 55805, United States	Recruiting
Research Site \| Minneapolis, Minnesota, 55404, United States	Recruiting
Research Site \| Morristown, New Jersey, 07962, United States	Terminated
Research Site \| Bronx, New York, 10469, United States	Withdrawn
Research Site \| New York, New York, 10028, United States	Terminated
Research Site \| New York, New York, 10065, United States	Recruiting
Research Site \| Port Jefferson Station, New York, 11776, United States	Terminated
Research Site \| Durham, North Carolina, 27710, United States	Recruiting
Research Site \| Bend, Oregon, 97701, United States	Recruiting
Research Site \| Medford, Oregon, 97504, United States	Terminated
Research Site \| Pittsburgh, Pennsylvania, 15212, United States	Recruiting
Research Site \| Charleston, South Carolina, 29414, United States	Recruiting
Research Site \| Charleston, South Carolina, 29424, United States	Recruiting
Research Site \| Sioux Falls, South Dakota, 57105, United States	Withdrawn
Research Site \| Austin, Texas, 78745, United States	Recruiting
Research Site \| Fort Worth, Texas, 76104, United States	Terminated
Research Site \| Houston, Texas, 77024, United States	Recruiting
Research Site \| Houston, Texas, 77030, United States	Recruiting
Research Site \| Houston, Texas, 77090, United States	Recruiting
Research Site \| Fairfax, Virginia, 22031, United States	Recruiting
Research Site \| Fort Belvoir, Virginia, 22060, United States	Recruiting
Research Site \| Kennewick, Washington, 99336, United States	Withdrawn
Research Site \| Kirkland, Washington, 98034, United States	Recruiting
Research Site \| Seattle, Washington, 98109, United States	Terminated
Research Site \| Buenos Aires, C1118AAT, Argentina	Recruiting
Research Site \| Caba, C1012AAR, Argentina	Recruiting
Research Site \| Caba, C1280AEB, Argentina	Recruiting
Research Site \| Ciudad Autonoma De Buenos Aire, C1125ABD, Argentina	Withdrawn
Research Site \| Florencio Varela, 1888, Argentina	Withdrawn
Research Site \| La Plata, 1900, Argentina	Recruiting
Research Site \| Pergamino, B2700CPM, Argentina	Recruiting
Research Site \| Rosario, S2000DEJ, Argentina	Recruiting
Research Site \| Rosario, S2000DSV, Argentina	Withdrawn
Research Site \| San Salvador de Jujuy, 4600, Argentina	Recruiting
Research Site \| Viedma, R8500ACE, Argentina	Recruiting
Research Site \| Graz, 8036, Austria	Recruiting
Research Site \| Innsbruck, 6020, Austria	Recruiting
Research Site \| Rankweil, 6830, Austria	Recruiting
Research Site \| Wien, 1090, Austria	Recruiting
Research Site \| Wien, 1210, Austria	Recruiting
Research Site \| Gent, 9000, Belgium	Recruiting
Research Site \| Liège, 4000, Belgium	Recruiting
Research Site \| Mons, 7000, Belgium	Recruiting
Research Site \| Barretos, 14784-400, Brazil	Recruiting
Research Site \| Belo Horizonte, 30380-090, Brazil	Recruiting
Research Site \| Campinas, 13060-904, Brazil	Recruiting
Research Site \| Curitiba, 81520-060, Brazil	Recruiting
Research Site \| Florianópolis, 88034-000, Brazil	Recruiting
Research Site \| Natal, 59075-740, Brazil	Recruiting
Research Site \| Porto Alegre, 90020-090, Brazil	Withdrawn
Research Site \| Porto Alegre, 90610-000, Brazil	Recruiting
Research Site \| Porto Alegre, 91350-200, Brazil	Withdrawn
Research Site \| Santa Maria, 97015-450, Brazil	Recruiting
Research Site \| Sao Paulo, 01246-000, Brazil	Recruiting
Research Site \| Sao Paulo, 01323-903, Brazil	Recruiting
Research Site \| Sao Paulo, 01509-900, Brazil	Withdrawn
Research Site \| São José do Rio Preto, 15090-000, Brazil	Recruiting
Research Site \| Teresina, 64049-200, Brazil	Not yet recruiting
Research Site \| Vitoria, 29043-260, Brazil	Recruiting
Research Site \| Plovdiv, 4004, Bulgaria	Recruiting
Research Site \| Sofia, 1330, Bulgaria	Recruiting
Research Site \| Sofia, 1407, Bulgaria	Recruiting
Research Site \| Sofia, 1618, Bulgaria	Recruiting
Research Site \| Sofia, 1797, Bulgaria	Recruiting
Research Site \| Varna, 9010, Bulgaria	Recruiting
Research Site \| Edmonton, Alberta, T6G 1Z2, Canada	Recruiting
Research Site \| Vancouver, British Columbia, V5Z 4E6, Canada	Withdrawn
Research Site \| Kitchener, Ontario, N2G 1G3, Canada	Recruiting
Research Site \| London, Ontario, N6A 4L6, Canada	Withdrawn
Research Site \| Levis, Quebec, G6V 3Z1, Canada	Recruiting
Research Site \| Montreal, Quebec, H1T 2M4, Canada	Recruiting
Research Site \| Montreal, Quebec, H4J 1C5, Canada	Recruiting
Research Site \| Saskatoon, Saskatchewan, S7N 4H4, Canada	Recruiting
Research Site \| Quebec, G1V 4G5, Canada	Recruiting
Research Site \| Santiago, 7500713, Chile	Recruiting
Research Site \| Santiago, 7500921, Chile	Recruiting
Research Site \| Santiago, 7520349, Chile	Recruiting
Research Site \| Santiago, 7560171, Chile	Not yet recruiting
Research Site \| Temuco, 4810469, Chile	Recruiting
Research Site \| Viña del Mar, 2540488, Chile	Recruiting
Research Site \| Beijing, 100021, China	Recruiting
Research Site \| Beijing, 100029, China	Recruiting
Research Site \| Beijing, 100029, China	Not yet recruiting
Research Site \| Beijing, 100050, China	Recruiting
Research Site \| Beijing, 100053, China	Not yet recruiting
Research Site \| Beijing, 100142, China	Withdrawn
Research Site \| Beijing, 100191, China	Recruiting
Research Site \| Beijing, China	Recruiting
Research Site \| Beijing, China	Withdrawn
Research Site \| Changchun, 130021, China	Withdrawn
Research Site \| Changsha, 410008, China	Recruiting
Research Site \| Changsha, 410013, China	Recruiting
Research Site \| Changsha, China	Withdrawn
Research Site \| Changzhou, 213000, China	Not yet recruiting
Research Site \| Chengdu, 610041, China	Recruiting
Research Site \| Guang Zhou, 510080, China	Withdrawn
Research Site \| Guangzhou, 510080, China	Withdrawn
Research Site \| Guangzhou, 510095, China	Not yet recruiting
Research Site \| Guangzhou, 510515, China	Recruiting
Research Site \| Guiyang, 550002, China	Not yet recruiting
Research Site \| Hangzhou, 310003, China	Recruiting
Research Site \| Hangzhou, 310006, China	Not yet recruiting
Research Site \| Hangzhou, 310022, China	Recruiting
Research Site \| Hangzhou, 310052, China	Recruiting
Research Site \| Hangzhou, China	Recruiting
Research Site \| Hefei, 230001, China	Recruiting
Research Site \| Kunming, 650118, China	Recruiting
Research Site \| Linhai, 317000, China	Recruiting
Research Site \| Nanchang, 330006, China	Recruiting
Research Site \| Nanjing, 210029, China	Not yet recruiting
Research Site \| Nanning, 530021, China	Not yet recruiting
Research Site \| Ningbo, 315010, China	Withdrawn
Research Site \| Ningbo, 315400, China	Recruiting
Research Site \| Shanghai, 200032, China	Not yet recruiting
Research Site \| Shanghai, 200032, China	Withdrawn
Research Site \| Shanghai, 200052, China	Recruiting
Research Site \| Shanghai, 200433, China	Recruiting
Research Site \| Shenyang, 110042, China	Recruiting
Research Site \| Shenyang, 110044, China	Recruiting
Research Site \| Shenzhen, 518035, China	Not yet recruiting
Research Site \| Shenzhen, 518036, China	Not yet recruiting
Research Site \| Tianjin, 300052, China	Withdrawn
Research Site \| Tianjin, 300060, China	Recruiting
Research Site \| Urumqi, 830000, China	Recruiting
Research Site \| Wuhan, 430060, China	Recruiting
Research Site \| Wuhan, 430079, China	Recruiting
Research Site \| Xiamen, 361004, China	Recruiting
Research Site \| Xian, 710061, China	Withdrawn
Research Site \| Xintai, 54031, China	Not yet recruiting
Research Site \| Yangzhou, 225001, China	Not yet recruiting
Research Site \| Zhengzhou, 450008, China	Recruiting
Research Site \| San José, 1000, Costa Rica	Recruiting
Research Site \| San José, Costa Rica	Recruiting
Research Site \| Avignon Cedex, 84902, France	Recruiting
Research Site \| Bordeaux, 33000, France	Withdrawn
Research Site \| Lyon Cedex 08, 69373, France	Recruiting
Research Site \| Nice, 06100, France	Recruiting
Research Site \| Toulon Cedex 9, 83800, France	Recruiting
Research Site \| Tours, 37000, France	Recruiting
Research Site \| Vantoux, 57070, France	Recruiting
Research Site \| Bielefeld, 33611, Germany	Recruiting
Research Site \| Frankfurt am Main, 60431, Germany	Recruiting
Research Site \| Göttingen, 37075, Germany	Withdrawn
Research Site \| Immenstadt im Allgäu, 87509, Germany	Recruiting
Research Site \| Köln, 51109, Germany	Recruiting
Research Site \| Budapest, 1121, Hungary	Recruiting
Research Site \| Budapest, 1121, Hungary	Terminated
Research Site \| Gyöngyös - Mátraháza, 3200, Hungary	Recruiting
Research Site \| Győr, 9024, Hungary	Recruiting
Research Site \| Törökbálint, 2045, Hungary	Recruiting
Research Site \| Ahmedabad, 380060, India	Recruiting
Research Site \| Bangalore, 560060, India	Withdrawn
Research Site \| Chandigarh, 160012, India	Withdrawn
Research Site \| Coimabatore, 641004, India	Withdrawn
Research Site \| Delhi, 110092, India	Recruiting
Research Site \| Erode, 638012, India	Withdrawn
Research Site \| Gurgaon, 122001, India	Recruiting
Research Site \| Gurgaon, 122002, India	Recruiting
Research Site \| Kolkata, 700160, India	Recruiting
Research Site \| Madurai, 625107, India	Withdrawn
Research Site \| Maharashtra, 411013, India	Recruiting
Research Site \| Manipal, 576104, India	Recruiting
Research Site \| Mumbai, 400012, India	Recruiting
Research Site \| Mumbai, 400053, India	Recruiting
Research Site \| Mysuru, 570017, India	Recruiting
Research Site \| Nagpur, 440012, India	Withdrawn
Research Site \| Namakkal, 637001, India	Recruiting
Research Site \| Nasik, 422002, India	Recruiting
Research Site \| New Delhi, 110063, India	Recruiting
Research Site \| New Delhi, 110076, India	Recruiting
Research Site \| New Delhi, 110085, India	Recruiting
Research Site \| Surat, 395009, India	Withdrawn
Research Site \| Thane, 401107, India	Recruiting
Research Site \| Vishakhapatnam, 530017, India	Recruiting
Research Site \| Ancona, 60126, Italy	Recruiting
Research Site \| Bari, 70124, Italy	Recruiting
Research Site \| Bergamo, 24127, Italy	Recruiting
Research Site \| Firenze, 50134, Italy	Recruiting
Research Site \| Milano, 20132, Italy	Recruiting
Research Site \| Monza, 20900, Italy	Recruiting
Research Site \| Padova, 35128, Italy	Recruiting
Research Site \| Roma, 00100, Italy	Recruiting
Research Site \| Verona, 37126, Italy	Recruiting
Research Site \| Habikino-shi, 583-8588, Japan	Active, not recruiting
Research Site \| Himeji-shi, 670-8520, Japan	Recruiting
Research Site \| Hiroshima-shi, 730-8518, Japan	Active, not recruiting
Research Site \| Hiroshima-shi, 734-8551, Japan	Recruiting
Research Site \| Iwakuni-shi, 740-8510, Japan	Recruiting
Research Site \| Kitaadachi-gun, 362-0806, Japan	Recruiting
Research Site \| Kitakyushu-shi, 807-8555, Japan	Active, not recruiting
Research Site \| Kurashiki shi, 701 0192, Japan	Recruiting
Research Site \| Nagoya-shi, 464-8681, Japan	Recruiting
Research Site \| Niigata-shi, 951-8566, Japan	Recruiting
Research Site \| Okayama-shi, 700-8558, Japan	Recruiting
Research Site \| Osakasayama-shi, 589-8511, Japan	Recruiting
Research Site \| Toyoake-shi, 470-1192, Japan	Recruiting
Research Site \| Wakayama-shi, 641-8510, Japan	Recruiting
Research Site \| Busan, 48108, Korea, Republic of	Recruiting
Research Site \| Cheongju-si, 28644, Korea, Republic of	Recruiting
Research Site \| Incheon, 21565, Korea, Republic of	Withdrawn
Research Site \| Seongnam-si, 13620, Korea, Republic of	Recruiting
Research Site \| Seoul, 05505, Korea, Republic of	Recruiting
Research Site \| Seoul, 06591, Korea, Republic of	Recruiting
Research Site \| Suwon-si, 16247, Korea, Republic of	Recruiting
Research Site \| Suwon-si, 16499, Korea, Republic of	Terminated
Research Site \| Aguascalientes, 20230, Mexico	Recruiting
Research Site \| Chihuahua, 31000, Mexico	Recruiting
Research Site \| Guadalajara, 44680, Mexico	Recruiting
Research Site \| Monterrey, 64000, Mexico	Recruiting
Research Site \| Monterrey, 64710, Mexico	Recruiting
Research Site \| México, 1400, Mexico	Recruiting
Research Site \| México, 14050, Mexico	Recruiting
Research Site \| Pachuca de Soto, 42090, Mexico	Recruiting
Research Site \| Arnhem, 6815 AD, Netherlands	Recruiting
Research Site \| Nijmegen, 6525 GA, Netherlands	Recruiting
Research Site \| Arequipa, 5154, Peru	Not yet recruiting
Research Site \| Bellavista, CALLAO 2, Peru	Recruiting
Research Site \| Cusco, CUSCO 01, Peru	Withdrawn
Research Site \| Lima, LIMA 11, Peru	Recruiting
Research Site \| Lima, LIMA 27, Peru	Withdrawn
Research Site \| Lima, LIMA 31, Peru	Recruiting
Research Site \| Lima, Lima 32, Peru	Recruiting
Research Site \| Lima, LIMA 34, Peru	Recruiting
Research Site \| San Isidro, 27, Peru	Recruiting
Research Site \| Davao City, 8000, Philippines	Recruiting
Research Site \| Iloilo City, 5000, Philippines	Recruiting
Research Site \| Makati, 1229, Philippines	Recruiting
Research Site \| Manila, 1000, Philippines	Suspended
Research Site \| Manila, 1015, Philippines	Recruiting
Research Site \| Quezon City, 1100, Philippines	Recruiting
Research Site \| Białystok, 15-276, Poland	Recruiting
Research Site \| Olsztyn, 10-357, Poland	Recruiting
Research Site \| Otwock, 05-400, Poland	Withdrawn
Research Site \| Szczecin, 71-455, Poland	Withdrawn
Research Site \| Warszawa, 01-138, Poland	Withdrawn
Research Site \| Warszawa, 02-781, Poland	Recruiting
Research Site \| Warszawa, 04-141, Poland	Recruiting
Research Site \| Wrocław, 53-439PL, Poland	Recruiting
Research Site \| Hato Rey Central, 00917, Puerto Rico	Recruiting
Research Site \| Cluj Napoca, 400015, Romania	Withdrawn
Research Site \| Constanta, 900591, Romania	Not yet recruiting
Research Site \| Craiova, 200347, Romania	Withdrawn
Research Site \| Iasi, 700483, Romania	Withdrawn
Research Site \| Suceava, 720237, Romania	Not yet recruiting
Research Site \| Ekaterinburg, 620905, Russian Federation	Withdrawn
Research Site \| Kazan, 420029, Russian Federation	Recruiting
Research Site \| Krasnoyarsk, 660133, Russian Federation	Recruiting
Research Site \| Lipetsk, 398005, Russian Federation	Withdrawn
Research Site \| Moscow, 105229, Russian Federation	Recruiting
Research Site \| Moscow, 115008, Russian Federation	Completed
Research Site \| Moscow, 115280, Russian Federation	Recruiting
Research Site \| Moscow, 121205, Russian Federation	Recruiting
Research Site \| Nizhniy Novgorod, 603081, Russian Federation	Recruiting
Research Site \| Obninsk, 249036, Russian Federation	Recruiting
Research Site \| Rostov-on-Don, 344037, Russian Federation	Recruiting
Research Site \| Saint Petersburg, 195271, Russian Federation	Withdrawn
Research Site \| St. Petersburg, 197022, Russian Federation	Suspended
Research Site \| Tomsk, 634063, Russian Federation	Recruiting
Research Site \| Yaroslavl, 150054, Russian Federation	Recruiting
Research Site \| Alicante, 03010, Spain	Recruiting
Research Site \| Barcelona, 08003, Spain	Suspended
Research Site \| Barcelona, 08036, Spain	Recruiting
Research Site \| Madrid, 28040, Spain	Recruiting
Research Site \| Madrid, 28041, Spain	Suspended
Research Site \| Málaga, 29010, Spain	Recruiting
Research Site \| Oviedo, 33011, Spain	Recruiting
Research Site \| Pamplona, 31008, Spain	Recruiting
Research Site \| San Sebastian, 20014, Spain	Recruiting
Research Site \| Santiago De Compostela(A Coru, 15706, Spain	Recruiting
Research Site \| Valencia, 46010, Spain	Suspended
Research Site \| Changhua, 500, Taiwan	Recruiting
Research Site \| Kaohsiung City, 83301, Taiwan	Withdrawn
Research Site \| Taichung City, 402, Taiwan	Recruiting
Research Site \| Taichung, 40705, Taiwan	Recruiting
Research Site \| Tainan City, 70403, Taiwan	Recruiting
Research Site \| Tainan City, 73657, Taiwan	Recruiting
Research Site \| Taipei City, 110, Taiwan	Recruiting
Research Site \| Taipei, 10002, Taiwan	Recruiting
Research Site \| Taipei, 235, Taiwan	Recruiting
Research Site \| Taoyuan, 333, Taiwan	Recruiting
Research Site \| Bangkok, 10300, Thailand	Recruiting
Research Site \| Bangkok, 10330, Thailand	Recruiting
Research Site \| Chiang Mai, 50200, Thailand	Recruiting
Research Site \| Chiang Rai, 57000, Thailand	Recruiting
Research Site \| Khon Kaen, 40002, Thailand	Recruiting
Research Site \| Lampang, 52000, Thailand	Recruiting
Research Site \| Dnipro, 49102, Ukraine	Withdrawn
Research Site \| Hanoi, 100000, Vietnam	Recruiting
Research Site \| Ho Chi Minh, 10000, Vietnam	Terminated
Research Site \| Ho Chi Minh, 700000, Vietnam	Recruiting
Research Site \| Ho Chi Minh, 70000, Vietnam	Recruiting

Расположение Страны	Argentina Austria Belgium Brazil Bulgaria Canada Chile China Costa Rica France Germany Hungary India Italy Japan Korea, Republic of Mexico Netherlands Peru Philippines Poland Puerto Rico Romania Russian Federation Spain Taiwan Thailand Ukraine United States Vietnam
Дата проверки	2021-10-01
Ответственная сторона	Тип: Sponsor
Ключевые слова	Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer
Имеет расширенный доступ	No
Состояние Просмотр	Lung Neoplasms Carcinoma, Non-Small-Cell Lung
Количество рук	2
Группа вооружений	Метка: Arm 1: Durvalumab + platinum-based chemotherapy Тип: Experimental Описание: Durvalumab (MEDI4736) in concurrence with platinum-based chemotherapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel cisplatin/gemcitabine pemetrexed/cisplatin pemetrexed/carboplatin Метка: Arm 2: Placebo + platinum-based chemotherapy Тип: Placebo Comparator Описание: Placebo in concurrence with platinum-based chemotherapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel cisplatin/gemcitabine pemetrexed/cisplatin pemetrexed/carboplatin
Акроним	AEGEAN
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Double (Participant, Care Provider)

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer