Lung Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

825

Study ID:

NCT03800134

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 219 Locations for this study

See Locations Near You

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Phoenix Arizona, 85054, United States
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Duarte California, 91010, United States
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Orange California, 92868, United States
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Aurora Colorado, 80012, United States
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Boca Raton Florida, 33486, United States
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Jacksonville Florida, 32256, United States
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Chicago Illinois, 60612, United States
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Wichita Kansas, 67214, United States
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Ashland Kentucky, 41101, United States
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Lexington Kentucky, 40513, United States
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Silver Spring Maryland, 20910, United States
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Towson Maryland, 21204, United States
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Duluth Minnesota, 55805, United States
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Minneapolis Minnesota, 55404, United States
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Morristown New Jersey, 07962, United States
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New York New York, 10028, United States
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New York New York, 10065, United States
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Port Jefferson Station New York, 11776, United States
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Durham North Carolina, 27710, United States
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Bend Oregon, 97701, United States
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Medford Oregon, 97504, United States
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Pittsburgh Pennsylvania, 15212, United States
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Charleston South Carolina, 29414, United States
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Charleston South Carolina, 29424, United States
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Austin Texas, 78745, United States
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Fort Worth Texas, 76104, United States
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Houston Texas, 77030, United States
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Houston Texas, 77090, United States
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Fairfax Virginia, 22031, United States
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Kirkland Washington, 98034, United States
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Seattle Washington, 98109, United States
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Buenos Aires , C1118, Argentina
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Caba , C1012, Argentina
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Caba , C1280, Argentina
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La Plata , 1900, Argentina
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Pergamino , B2700, Argentina
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Rosario , S2000, Argentina
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San Salvador de Jujuy , 4600, Argentina
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Viedma , R8500, Argentina
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Graz , 8036, Austria
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Innsbruck , 6020, Austria
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Rankweil , 6830, Austria
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Wien , 1090, Austria
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Wien , 1210, Austria
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Gent , 9000, Belgium
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Liège , 4000, Belgium
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Mons , 7000, Belgium
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Barretos , 14784, Brazil
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Belo Horizonte , 30380, Brazil
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Campinas , 13060, Brazil
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Curitiba , 81520, Brazil
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Florianópolis , 88034, Brazil
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Natal , 59075, Brazil
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Porto Alegre , 90610, Brazil
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Santa Maria , 97015, Brazil
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Sao Paulo , 01246, Brazil
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Sao Paulo , 01323, Brazil
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São José do Rio Preto , 15090, Brazil
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Teresina , 64049, Brazil
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Vitoria , 29043, Brazil
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Plovdiv , 4004, Bulgaria
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Sofia , 1330, Bulgaria
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Sofia , 1407, Bulgaria
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Sofia , 1797, Bulgaria
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Edmonton Alberta, T6G 1, Canada
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Kitchener Ontario, N2G 1, Canada
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Levis Quebec, G6V 3, Canada
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Montreal Quebec, H1T 2, Canada
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Montreal Quebec, H4J 1, Canada
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Saskatoon Saskatchewan, S7N 4, Canada
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Quebec , G1V 4, Canada
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Santiago , 75007, Chile
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Santiago , 75009, Chile
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Temuco , 48104, Chile
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Viña del Mar , 25404, Chile
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Beijing , 10002, China
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Beijing , 10002, China
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Beijing , 10019, China
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Beijing , , China
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Changsha , 41000, China
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Changsha , 41001, China
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Changzhou , 21300, China
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Chengdu , 61004, China
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Guangzhou , 51009, China
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Guangzhou , 51051, China
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Guiyang , 55000, China
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Hangzhou , 31000, China
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Hangzhou , 31002, China
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Hangzhou , 31005, China
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Hangzhou , , China
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Hefei , 23000, China
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Kunming , 65011, China
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Linhai , 31700, China
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Nanchang , 33000, China
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Ningbo , 31500, China
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Shanghai , 20005, China
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Shanghai , 20043, China
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Shenyang , 11004, China
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Shenyang , 11004, China
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Shenzhen , 51803, China
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Shenzhen , 51803, China
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Tianjin , 30006, China
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Urumqi , 83000, China
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Wuhan , 43006, China
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Wuhan , 43007, China
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Xiamen , 36100, China
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Xintai , 54031, China
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Yangzhou , 22500, China
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Zhengzhou , 45000, China
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San José , 1000, Costa Rica
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San José , , Costa Rica
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Avignon Cedex , 84902, France
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Lyon Cedex 08 , 69373, France
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Nice , 06100, France
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Toulon Cedex 9 , 83800, France
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Vantoux , 57070, France
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Bielefeld , 33611, Germany
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Frankfurt am Main , 60431, Germany
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Immenstadt , 87509, Germany
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Köln , 51109, Germany
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Budapest , 1121, Hungary
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Gyöngyös - Mátraháza , 3200, Hungary
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Győr , 9024, Hungary
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Székesfehérvár , 8000, Hungary
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Törökbálint , 2045, Hungary
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Ahmedabad , 38006, India
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Gurgaon , 12200, India
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Gurgaon , 12200, India
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Kolkata , 70016, India
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Manipal , 57610, India
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Mumbai , 40001, India
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Mumbai , 40005, India
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Mysuru , 57001, India
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Namakkal , 63700, India
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Nashik , 42200, India
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New Delhi , 11007, India
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New Delhi , 11008, India
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Thane , 40110, India
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Vishakhapatnam , 53001, India
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Ancona , 60126, Italy
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Bari , 70124, Italy
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Bergamo , 24127, Italy
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Firenze , 50134, Italy
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Milano , 20132, Italy
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Monza , 20900, Italy
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Padova , 35128, Italy
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Roma , 00100, Italy
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Verona , 37126, Italy
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Habikino-shi , 583-8, Japan
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Himeji-shi , 670-8, Japan
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Hiroshima-shi , 730-8, Japan
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Hiroshima-shi , 734-8, Japan
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Iwakuni-shi , 740-8, Japan
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Kitaadachi-gun , 362-0, Japan
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Kitakyushu-shi , 807-8, Japan
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Kurashiki shi , 701 0, Japan
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Nagoya-shi , 464-8, Japan
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Niigata-shi , 951-8, Japan
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Okayama-shi , 700-8, Japan
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Osakasayama-shi , 589-8, Japan
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Toyoake-shi , 470-1, Japan
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Wakayama-shi , 641-8, Japan
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Busan , 48108, Korea, Republic of
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Cheongju-si , 28644, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Suwon-si , 16247, Korea, Republic of
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Suwon-si , 16499, Korea, Republic of
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Aguascalientes , 20230, Mexico
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Chihuahua , 31000, Mexico
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Guadalajara , 44680, Mexico
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Monterrey , 64000, Mexico
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Monterrey , 64710, Mexico
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México , 1400, Mexico
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México , 14050, Mexico
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Pachuca de Soto , 42090, Mexico
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Arnhem , 6815 , Netherlands
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Nijmegen , 6525 , Netherlands
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Bellavista , CALLA, Peru
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Lima , LIMA , Peru
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Lima , LIMA , Peru
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Lima , Lima , Peru
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Lima , LIMA , Peru
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Davao City , 8000, Philippines
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Iloilo City , 5000, Philippines
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Makati , 1229, Philippines
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Quezon City , 1100, Philippines
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Białystok , 15-27, Poland
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Kraków , 31-20, Poland
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Olsztyn , 10-35, Poland
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Poznań , 60-56, Poland
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Warszawa , 02-78, Poland
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Warszawa , 04-14, Poland
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Wrocław , 53-43, Poland
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Suceava , 72023, Romania
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Kazan , 42002, Russian Federation
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Krasnoyarsk , 66013, Russian Federation
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Moscow , 10522, Russian Federation
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Moscow , 11500, Russian Federation
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Moscow , 11528, Russian Federation
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Moscow , 12120, Russian Federation
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Nizhniy Novgorod , 60308, Russian Federation
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Obninsk , 24903, Russian Federation
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Rostov-on-Don , 34403, Russian Federation
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St. Petersburg , 19702, Russian Federation
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Tomsk , 63406, Russian Federation
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Yaroslavl , 15005, Russian Federation
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Alicante , 03010, Spain
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Barcelona , 08036, Spain
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Madrid , 28040, Spain
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Málaga , 29010, Spain
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Oviedo , 33011, Spain
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Pamplona , 31008, Spain
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San Sebastian , 20014, Spain
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Santiago De Compostela (A Coruña) , 15706, Spain
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Changhua , 500, Taiwan
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Taichung City , 402, Taiwan
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Taichung , 40705, Taiwan
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Tainan City , 70403, Taiwan
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Tainan City , 73657, Taiwan
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Taipei City , 110, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 235, Taiwan
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Bangkok , 10300, Thailand
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Bangkok , 10330, Thailand
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Chiang Mai , 50200, Thailand
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Chiang Rai , 57000, Thailand
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Khon Kaen , 40002, Thailand
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Lampang , 52000, Thailand
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Hanoi , 10000, Vietnam
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Ho Chi Minh , 10000, Vietnam
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Ho Chi Minh , 70000, Vietnam
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Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

825

Study ID:

NCT03800134

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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