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
NCT ID: NCT01933932
Last Updated: 2025-11-19
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
510 participants
INTERVENTIONAL
2013-09-25
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Selumetinib + Docetaxel
Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
Selumetinib
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
Docetaxel
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Pegylated G-CSF
All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Placebo + Docetaxel
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Docetaxel
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Placebo
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Pegylated G-CSF
All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Interventions
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Selumetinib
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
Docetaxel
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Placebo
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Pegylated G-CSF
All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Gabriella Mariani, MD
Role: STUDY_CHAIR
AstraZeneca UK, MSD
Pasi Jänne, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Faber Cancer Institute, USA
Locations
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Research Site
Aurora, Colorado, United States
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Pembroke Pines, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Metairie, Louisiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Danvers, Massachusetts, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Rosario, , Argentina
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Camperdown, , Australia
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Chermside, , Australia
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Darlinghurst, , Australia
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Fitzroy, , Australia
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Kogarah, , Australia
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Kurralta Park, , Australia
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Malvern, , Australia
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Wendouree, , Australia
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Woodville South, , Australia
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Innsbruck, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Barretos, , Brazil
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Ijuí, , Brazil
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Pelotas, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Vratsa, , Bulgaria
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Brest, , France
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Caen, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Lille, , France
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Marseille, , France
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Paris, , France
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Pierre-Bénite, , France
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Rennes, , France
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Toulouse, , France
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Augsburg, , Germany
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Bad Berka, , Germany
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Cologne, , Germany
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Dortmund, , Germany
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Gerlingen, , Germany
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Großhansdorf, , Germany
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Halle, , Germany
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Heidelberg, , Germany
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Homburg, , Germany
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Löwenstein, , Germany
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Moers, , Germany
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München, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Würzburg, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Edelény, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Törökbálint, , Hungary
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Beersheba, , Israel
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Haifa, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Bari, , Italy
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Genova, , Italy
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Livorno, , Italy
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Milan, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Parma, , Italy
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Perugia, , Italy
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Roma, , Italy
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Roma, , Italy
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México, , Mexico
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Monterrey, , Mexico
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Bergen op Zoom, , Netherlands
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Maastricht, , Netherlands
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Miraflores, , Peru
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Brzozów, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gdansk, , Poland
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Grudziądz, , Poland
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Krakow, , Poland
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Lubin, , Poland
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Olsztyn, , Poland
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Opole, , Poland
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Sucha Beskidzka, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Amadora, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Kazan', , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Volgograd, , Russia
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Vigo(Pontevedra), , Spain
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Zaragoza, , Spain
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Linköping, , Sweden
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Örebro, , Sweden
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Uppsala, , Sweden
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Manisa, , Turkey (Türkiye)
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Chernivtsі, , Ukraine
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Dnipro, , Ukraine
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Kharkiv Region, , Ukraine
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Kryvyi Rih, , Ukraine
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Kyiv, , Ukraine
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Sumy, , Ukraine
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Uzhhorod, , Ukraine
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Zaporizhzhia, , Ukraine
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Aberdeen, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
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Sutton, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Janne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crino L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial. JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.
Janne PA, Mann H, Ghiorghiu D. Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1). Clin Lung Cancer. 2016 Mar;17(2):e1-4. doi: 10.1016/j.cllc.2015.12.010. Epub 2015 Dec 30.
Related Links
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Other Identifiers
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2013-001676-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1532C00079
Identifier Type: -
Identifier Source: org_study_id
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