Lung Cancer Clinical Trial

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

Summary

To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

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Full Description

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of AZD9291 versus placebo in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy. Adjuvant chemotherapy should have consisted of a platinum based doublet given for a maximum of 4 cycles.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female, aged at least 18 years.
Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology
MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.
Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
World Health Organization Performance Status of 0 to 1.
Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential.

Exclusion Criteria:

Treatment with any of the following:

Pre-operative or post-operative or planned radiation therapy for the current lung cancer
Pre-operative (neo-adjuvant) platinum based or other chemotherapy
Any prior anticancer therapy
Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug
Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
Treatment with an investigational drug within five half-lives of the compound or any of its related material.
Patients who have had only segmentectomies or wedge resections
History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.

Any of the following cardiac criteria:

Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
Inadequate bone marrow reserve or organ function.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

682

Study ID:

NCT02511106

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 231 Locations for this study

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Los Angeles California, 90048, United States
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Santa Monica California, 90404, United States
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Santa Rosa California, 95403, United States
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Torrance California, 90505, United States
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Grand Junction Colorado, 81501, United States
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New Haven Connecticut, 06520, United States
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Norwalk Connecticut, 06856, United States
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Fort Myers Florida, 33901, United States
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Pembroke Pines Florida, 33028, United States
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Saint Petersburg Florida, 33705, United States
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Athens Georgia, 30607, United States
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Honolulu Hawaii, 96819, United States
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Chicago Illinois, 60612, United States
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Elk Grove Village Illinois, 60007, United States
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Bethesda Maryland, 20817, United States
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Brick New Jersey, 08724, United States
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Florham Park New Jersey, 07932, United States
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Mineola New York, 11501, United States
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Pawtucket Rhode Island, 02860, United States
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Chattanooga Tennessee, 37404, United States
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Nashville Tennessee, 37203, United States
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San Antonio Texas, 78229, United States
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Fort Belvoir Virginia, 22060, United States
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Bedford Park , 5042, Australia
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Camperdown , 2050, Australia
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Darlinghurst , 2010, Australia
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Heidelberg , 3084, Australia
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Kogarah , 2217, Australia
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Kurralta Park , 5037, Australia
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Woolloongabba , 4102, Australia
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Brussels , 1090, Belgium
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Brussel , 1200, Belgium
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Gent , 9000, Belgium
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Kortrijk , 8500, Belgium
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Barretos , 14784, Brazil
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Cachoeira De Itapemirim , 29308, Brazil
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Curitiba , 81520, Brazil
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Florianópolis , 88034, Brazil
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Fortaleza , 60810, Brazil
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Lajeado , 95900, Brazil
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Porto Alegre , 90619, Brazil
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Rio de Janeiro , 22793, Brazil
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Salvador , 40170, Brazil
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São José do Rio Preto , 15025, Brazil
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São Paulo , 01321, Brazil
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Toronto Ontario, M5G 2, Canada
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Beijing , 10002, China
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Beijing , 10014, China
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Beijing , 10021, China
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Beijing , 10073, China
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Changchun , 13001, China
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Changchun , 13002, China
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Dalian , 11602, China
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Guangzhou , 51006, China
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Guangzhou , 51012, China
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Guangzhou , 51018, China
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Hangzhou , 31000, China
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Hangzhou , 31000, China
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Hangzhou , 31002, China
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Kunming , 65011, China
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Nanjing , 21002, China
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Nanning , 53002, China
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Shanghai , 20003, China
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Shanghai , 20003, China
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Shanghai , 20007, China
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Shenyang , 11000, China
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Suzhou , 21500, China
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Tianjin , 30005, China
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Tianjin , 30005, China
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Tianjin , 30006, China
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Urumqi , 83000, China
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Xi'an , 71006, China
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Xiamen , 36100, China
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Yangzhou , 22500, China
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Zhengzhou , 45000, China
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Ürümqi , 83000, China
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Bron , 69677, France
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Lille , 59000, France
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Limoges Cedex , 87042, France
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Lyon , 69008, France
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Paris , 75020, France
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Aachen , 52074, Germany
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Berlin , 12351, Germany
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Berlin , 13125, Germany
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Berlin , 13359, Germany
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Coswig , 01640, Germany
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Gauting , 82131, Germany
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Gerlingen , 70839, Germany
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Großhansdorf , 22927, Germany
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Halle , 06120, Germany
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Hamburg , 20251, Germany
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Homburg , 66421, Germany
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Immenhausen , 34376, Germany
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Kassel , 34125, Germany
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Köln , 51109, Germany
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Lübeck , 23538, Germany
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Würzburg , 97074, Germany
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Hong Kong , 15000, Hong Kong
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Hong Kong , , Hong Kong
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King's Park , 15000, Hong Kong
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Budapest , 1083, Hungary
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Budapest , 1121, Hungary
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Deszk , 6772, Hungary
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Székesfehérvár , 8000, Hungary
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Törökbálint , 2045, Hungary
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Beer-Sheva , 84101, Israel
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Haifa , 31999, Israel
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Jerusalem , 91120, Israel
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Kfar-Saba , 44281, Israel
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Petah Tikva , 49414, Israel
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Ramat Gan , 52620, Israel
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Tel Aviv , 64239, Israel
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Bari , 70124, Italy
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Bergamo , 24127, Italy
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Bologna , 40138, Italy
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Cremona , 26100, Italy
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Firenze , 50134, Italy
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Lucca , 55100, Italy
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Meldola , 47014, Italy
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Milano , 20132, Italy
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Milano , 20141, Italy
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Milano , 20162, Italy
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Novara , 28100, Italy
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Orbassano , 10043, Italy
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Padova , 35128, Italy
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Parma , 43126, Italy
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Roma , 00152, Italy
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Bunkyo-ku , 113-8, Japan
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Fukuoka , 812-8, Japan
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Hirakata-shi , 573-1, Japan
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Hiroshima-shi , 730-8, Japan
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Hiroshima-shi , 734-8, Japan
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Kanazawa , 920-8, Japan
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Kashiwa , 277-8, Japan
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Kitakyushu-shi , 807-8, Japan
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Kobe-shi , 650-0, Japan
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Kurume-shi , 830-0, Japan
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Matsuyama-shi , 791-0, Japan
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Nagoya-shi , 453-8, Japan
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Niigata-shi , 951-8, Japan
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Osakasayama-shi , 589-8, Japan
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Sagamihara-shi , 252-0, Japan
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Sakai-shi , 591-8, Japan
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Sasebo-shi , 857-8, Japan
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Sendai-shi , 980-0, Japan
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Shinjuku-ku , 160-0, Japan
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Sunto-gun , 411-8, Japan
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Ube-shi , 755-0, Japan
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Yokohama-shi , 240-8, Japan
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Yokohama-shi , 241-8, Japan
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Yonago-shi , 683-8, Japan
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Cheongju-si , 28644, Korea, Republic of
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Seoul , 02841, Korea, Republic of
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Seoul , 05030, Korea, Republic of
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Seoul , 138-7, Korea, Republic of
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Seoul , 156-7, Korea, Republic of
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Seoul , 6351, Korea, Republic of
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Suwon-si , 16247, Korea, Republic of
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Suwon , 16499, Korea, Republic of
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Amsterdam , 1081 , Netherlands
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Arnhem , 6815 , Netherlands
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Hoofddorp , 2134 , Netherlands
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Zwolle , 8025 , Netherlands
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Kraków , 31-20, Poland
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Otwock , 05-40, Poland
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Poznan , 60-56, Poland
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Poznań , 60-56, Poland
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Racibórz , 47-40, Poland
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Warszawa , 02-78, Poland
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Wieliszew , 05-13, Poland
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Łódź , 90-30, Poland
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Bucharest , 05009, Romania
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Bucuresti , 03142, Romania
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Cluj Napoca , 40001, Romania
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Craiova , 20038, Romania
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Focsani , 62016, Romania
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Iasi , 70048, Romania
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Timisoara , 30021, Romania
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Arkhangelsk , 16304, Russian Federation
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Kazan , 42002, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 14342, Russian Federation
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Obninsk , 24903, Russian Federation
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Omsk , 64401, Russian Federation
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Pyatigorsk , 35750, Russian Federation
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Rostov-on-Don , 34403, Russian Federation
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Ryazan , 39001, Russian Federation
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Saint Petersburg , 19429, Russian Federation
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Saint Petersburg , 19527, Russian Federation
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Saint Petersburg , 19825, Russian Federation
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Saint-Petersburg , 19775, Russian Federation
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Sankt-Peterburg , 19775, Russian Federation
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St. Petersburg , 19702, Russian Federation
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A Coruña , 15006, Spain
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Barcelona , 08041, Spain
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Elche , 03203, Spain
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Las Palmas de Gran Canaria , 35016, Spain
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Madrid , 08035, Spain
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Madrid , 28007, Spain
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Madrid , 28040, Spain
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Madrid , 28046, Spain
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Majadahonda , 28222, Spain
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Málaga , 29010, Spain
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San Sebastian , 20014, Spain
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Valencia , 46010, Spain
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Valencia , 46026, Spain
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Zaragoza , 50009, Spain
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Linköping , 581 8, Sweden
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Changhua , 50006, Taiwan
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Putzu City , 0613, Taiwan
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Taichung City , 402, Taiwan
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Taichung , 40705, Taiwan
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Tainan City , 73657, Taiwan
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Tainan , 70403, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 112, Taiwan
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Tao-Yuan , 333, Taiwan
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Bangkok , 10330, Thailand
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Bangkok , 10700, Thailand
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Chiang Rai , 57000, Thailand
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Khon Kaen , 40002, Thailand
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Mueang , 50200, Thailand
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Phitsanulok , 65000, Thailand
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Songkla , 90110, Thailand
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Ankara , 06280, Turkey
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Ankara , 6500, Turkey
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Bursa , 16059, Turkey
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Istanbul , 34069, Turkey
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Istanbul , 34093, Turkey
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Istanbul , 34098, Turkey
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Istanbul , 34722, Turkey
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Izmir , 35100, Turkey
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Dnipro , 49102, Ukraine
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Lviv , 79031, Ukraine
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Sumy , 40022, Ukraine
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Uzhhorod , 88000, Ukraine
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Vinnytsia , 21029, Ukraine
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Zaporizhzhia , 69040, Ukraine
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Hanoi , 10000, Vietnam
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Hanoi , 10000, 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:

682

Study ID:

NCT02511106

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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