Lung Cancer Clinical Trial

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Summary

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

View Full Description

Full Description

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Provision of signed, written and dated informed consent prior to any study specific procedures
Male or female, aged 18 years or older
Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
KRAS mutation positive tumour sample as determined by the designated testing laboratory
Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy

Exclusion Criteria:

Mixed small cell and non-small cell lung cancer histology.
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
Other concomitant anti-cancer therapy agents excepts steroids
Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

510

Study ID:

NCT01933932

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 191 Locations for this study

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Aurora Colorado, 80045, United States
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Pembroke Pines Florida, 33028, United States
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Atlanta Georgia, 30318, United States
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Chicago Illinois, 60637, United States
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Metairie Louisiana, 70006, United States
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Boston Massachusetts, 02114, United States
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Boston Massachusetts, 02215, United States
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Danvers Massachusetts, 01923, United States
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New York New York, 10011, United States
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New York New York, 10032, United States
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Durham North Carolina, 27710, United States
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Hershey Pennsylvania, 17033, United States
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Philadelphia Pennsylvania, 19107, United States
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Nashville Tennessee, 37203, United States
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Nashville Tennessee, 37232, United States
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Seattle Washington, 98104, United States
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Morgantown West Virginia, 26506, United States
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Buenos Aires , 1426, Argentina
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Buenos Aires , C1025, Argentina
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Ciudad de Buenos Aires , 1180, Argentina
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Cordoba , 5000, Argentina
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Rosario , S2000, Argentina
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Camperdown , 2050, Australia
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Chermside , 4032, Australia
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Darlinghurst , 2010, Australia
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Fitzroy , 3065, Australia
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Kogarah , 2217, Australia
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Kurralta Park , 5037, Australia
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Malvern , 3144, Australia
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Wendouree , 3355, Australia
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Woodville South , 5011, Australia
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Innsbruck , 6020, Austria
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Linz , 4020, Austria
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Salzburg , 5020, Austria
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Vienna , 1160, Austria
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Wien , 1100, Austria
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Brussels , 1090, Belgium
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Bruxelles , 1000, Belgium
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Bruxelles , 1200, Belgium
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Gent , 9000, Belgium
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Leuven , 3000, Belgium
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Roeselare , 8800, Belgium
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Barretos , 14784, Brazil
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Ijui , 98700, Brazil
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Pelotas , 09601, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90610, Brazil
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Sao Paulo , 01209, Brazil
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Sao Paulo , 01246, Brazil
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Sao Paulo , , Brazil
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São José do Rio Preto , 15090, Brazil
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Plovdiv , 4000, Bulgaria
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Sofia , 1233, Bulgaria
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Sofia , 1303, Bulgaria
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Sofia , 1330, Bulgaria
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Varna , 9010, Bulgaria
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Vratza , 3000, Bulgaria
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Edmonton Alberta, T6G 1, Canada
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Kelowna British Columbia, V1Y 5, Canada
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Surrey British Columbia, V3V 1, Canada
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Halifax Nova Scotia, B3H 1, Canada
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Oshawa Ontario, L1G 2, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H4A 3, Canada
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Regina Saskatchewan, S4T 7, Canada
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Saskatoon Saskatchewan, S7N 4, Canada
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Quebec , G1V 4, Canada
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Santiago , 75009, Chile
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Santiago , 75203, Chile
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Santiago , 76303, Chile
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Santiago , 83601, Chile
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Santiago , 83804, Chile
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Santiago , 84203, Chile
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Brest Cedex , 29609, France
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Caen , F-140, France
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Clermont Ferrand , 63003, France
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Dijon , 21079, France
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Lille , 59000, France
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Marseille Cedex 20 , 13915, France
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Paris , 75020, France
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Pierre Benite Cedex , 69310, France
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RENNES Cedex 9 , 35033, France
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Toulouse Cedex 09 , 31059, France
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Augsburg , 86156, Germany
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Bad Berka , 99437, Germany
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Dortmund , 44309, 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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Heidelberg , 69126, Germany
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Homburg , 66424, Germany
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Köln , 50937, Germany
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Löwenstein , 74245, Germany
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Moers , 47441, Germany
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München , 81925, Germany
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Ulm , 89081, Germany
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Wiesbaden , 65199, Germany
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Würzburg , 97080, Germany
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Budapest , 1121, Hungary
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Budapest , 1122, Hungary
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Edelény , 3780, Hungary
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Győr , 9024, Hungary
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Kaposvár , 7400, Hungary
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Miskolc , 3529, Hungary
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Nyíregyháza , 4400, Hungary
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Törökbálint , 2045, Hungary
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Beer Sheva , 84101, Israel
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Haifa , 31096, Israel
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Kfar Saba , 44281, Israel
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Petah Tikva , 49100, Israel
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Tel Hashomer , 52621, Israel
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Tel-Aviv , 64239, Israel
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Bari , 70124, Italy
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Genova , 16100, Italy
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Livorno , 57100, Italy
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Milano , 20132, Italy
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Napoli , 80131, Italy
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Orbassano , 10043, Italy
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Parma , 43126, Italy
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Perugia , 06132, Italy
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Roma , 00128, Italy
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Roma , 00144, Italy
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Mexico , 14080, Mexico
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Monterrey , 64460, Mexico
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Amsterdam , 1066 , Netherlands
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Amsterdam , 1081 , Netherlands
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Bergen Op Zoom , 4624 , Netherlands
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Den Bosch , 5223 , Netherlands
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Maastricht , 6202 , Netherlands
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Lima , 15033, Peru
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Lima , 15073, Peru
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Lima , L27, 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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Miraflores , 15046, Peru
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Brzozow , 36-20, Poland
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Bydgoszcz , 85-79, Poland
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Gdańsk , 80-21, Poland
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Gdańsk , 80-21, Poland
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GrudziÄ…dz , 86-30, Poland
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Kraków , 31-20, Poland
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Lubin , 59-30, Poland
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Olsztyn , 10-35, Poland
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Opole , 45-06, Poland
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Sucha Beskidzka , 34-20, Poland
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Szczecin , 70-89, Poland
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Warszawa , 02-78, Poland
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Amadora , 2720-, Portugal
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Coimbra , 3040-, Portugal
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Lisboa , 1099-, Portugal
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Lisboa , 1769-, Portugal
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Porto , 4100-, Portugal
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Porto , 4200-, Portugal
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Vila Nova de Gaia , 4434-, Portugal
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Cluj Napoca , 40001, Romania
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Cluj Napoca , 40005, Romania
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Kazan , 42001, Russian Federation
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Moscow , 10522, Russian Federation
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Moscow , 11547, Russian Federation
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Saint Petersburg , 19734, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Saint-Petersburg , 19429, Russian Federation
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Volgograd , 40013, Russian Federation
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Barcelona , 08003, Spain
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Madrid , 08035, Spain
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Madrid , 28034, Spain
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Madrid , 28041, Spain
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Málaga , 29010, Spain
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Sevilla , 41013, Spain
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Vigo(Pontevedra) , 36204, Spain
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Zaragoza , 50009, Spain
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Linköping , 581 8, Sweden
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Uppsala , SE-75, Sweden
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Örebro , 701 8, Sweden
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Ankara , 06230, Turkey
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Ankara , 06280, Turkey
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Istanbul , 34662, Turkey
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Ä°stanbul , 34844, Turkey
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Izmir , 35100, Turkey
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Izmir , 35110, Turkey
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Manisa , 45030, Turkey
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ChernivtsÑ– , 58013, Ukraine
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Dnipro , 49102, Ukraine
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Kharkiv Region , 61070, Ukraine
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Kryvyi Rih , 50048, Ukraine
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Kyiv , 03115, Ukraine
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Sumy , 40022, Ukraine
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Uzhhorod , 88000, Ukraine
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Zaporizhzhia , 69040, Ukraine
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Aberdeen , AB2 2, United Kingdom
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London , SW3 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Nottingham , NG5 1, United Kingdom
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Sutton , SM2 5, United Kingdom
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Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

510

Study ID:

NCT01933932

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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