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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00949910
Registration number
NCT00949910
Ethics application status
Date submitted
15/04/2009
Date registered
31/07/2009
Date last updated
5/10/2016
Titles & IDs
Public title
An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
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Secondary ID [1]
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0
2004-000564-28
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Secondary ID [2]
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0
MO18109
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Lung - Mesothelioma
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Cancer
0
0
0
0
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Lung - Non small cell
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Cancer
0
0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Erlotinib
Experimental: Erlotinib - Erlotinib will be given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Treatment will continue until unacceptable toxicity, disease progression, or withdrawal for any other reason.
Treatment: Drugs: Erlotinib
Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
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Assessment method [1]
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Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (=) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed =28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.
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Timepoint [1]
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Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
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Secondary outcome [1]
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Percentage of Participants With Disease Control According to RECIST
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Assessment method [1]
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Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as =30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed =28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (\<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.
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Timepoint [1]
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Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
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Secondary outcome [2]
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0
Percentage of Participants by Best Overall Response According to RECIST
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Assessment method [2]
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Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as =30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed =28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but \<20% increase in sum LD. Disease progression or progressive disease (PD) was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is \<1) with each type of best overall response was reported.
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Timepoint [2]
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Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
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Secondary outcome [3]
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Percentage of Participants With Death or Disease Progression According to RECIST
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Assessment method [3]
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Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.
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Timepoint [3]
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0
Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
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Secondary outcome [4]
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0
Progression-Free Survival (PFS) According to RECIST
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Assessment method [4]
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0
Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.
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Timepoint [4]
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Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
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Secondary outcome [5]
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Percentage of Participants Who Died
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Assessment method [5]
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0
The percentage of participants (in nearest integer) who died from any cause was reported.
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Timepoint [5]
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Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
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Timepoint [6]
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Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
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Eligibility
Key inclusion criteria
* Adults greater than or equal to (=) 18 years of age
* Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC
* Previous treatment with no more than 2 prior chemotherapy regimens
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors
* Inability to take oral medication
* Any other malignancies within 5 years
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2009
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Sample size
Target
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Accrual to date
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Final
6586
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Recruitment in Australia
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- Adelaide
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- Camperdown
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- Frankston
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- Kurralta Park
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- Wollongong
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5011 - Adelaide
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2050 - Camperdown
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4032 - Chermside
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Recruitment postcode(s) [4]
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3199 - Frankston
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6160 - Fremantle
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3220 - Geelong
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Recruitment postcode(s) [7]
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5037 - Kurralta Park
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3144 - Malvern
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3002 - Melbourne
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3084 - Melbourne
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Recruitment postcode(s) [11]
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6009 - Perth
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Recruitment postcode(s) [12]
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2065 - St. Leonards
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2031 - Sydney
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2217 - Sydney
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4224 - Tugun
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Recruitment postcode(s) [16]
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2298 - Waratah
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Recruitment postcode(s) [17]
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3690 - Wodonga
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Recruitment postcode(s) [18]
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2500 - Wollongong
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Recruitment outside Australia
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Albania
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Tirana
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Salta
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Bludesch
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Kufstein
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Natters
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Oberpullendorf
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Country [105]
0
0
Finland
Query!
State/province [105]
0
0
Turku
Query!
Country [106]
0
0
Finland
Query!
State/province [106]
0
0
Vaasa
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Amberg
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Augsburg
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Aurich
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Bad Berka
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Berlin
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Bonn
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Celle
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Dortmund
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Dresden
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Essen
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Flensburg
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Frankfurt Am Main
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Frankfurt
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Freiburg
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Gauting
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Gerlingen
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Giessen
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Grosshansdorf
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Halle (saale)
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Hamburg
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Heidelberg
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Herne
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Homburg/Saar
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Kassel
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Koblenz
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Köln
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Leipzig
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Leverkusen
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Lostau
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Löwenstein
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Lübeck
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Mainz
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Mannheim
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Minden
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Muenchen
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Mönchengladbach
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
München
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Neuruppin
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Nürnberg
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Oldenburg
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Osnabrück
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Rostock
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Saarbruecken
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Trier
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Ulm
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Wangen
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Wiesbaden
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Wuerselen
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Wuppertal
Query!
Country [156]
0
0
Greece
Query!
State/province [156]
0
0
Athens
Query!
Country [157]
0
0
Greece
Query!
State/province [157]
0
0
Haidari
Query!
Country [158]
0
0
Greece
Query!
State/province [158]
0
0
Heraklion
Query!
Country [159]
0
0
Greece
Query!
State/province [159]
0
0
Neo Faliro
Query!
Country [160]
0
0
Greece
Query!
State/province [160]
0
0
Thessaloniki
Query!
Country [161]
0
0
Guatemala
Query!
State/province [161]
0
0
Guatemala City
Query!
Country [162]
0
0
Hong Kong
Query!
State/province [162]
0
0
Hong Kong
Query!
Country [163]
0
0
Hungary
Query!
State/province [163]
0
0
Budapest
Query!
Country [164]
0
0
Hungary
Query!
State/province [164]
0
0
Deszk
Query!
Country [165]
0
0
Hungary
Query!
State/province [165]
0
0
Kecskemet
Query!
Country [166]
0
0
Hungary
Query!
State/province [166]
0
0
Mátraháza
Query!
Country [167]
0
0
Hungary
Query!
State/province [167]
0
0
Nyíregyháza
Query!
Country [168]
0
0
Hungary
Query!
State/province [168]
0
0
Pecs
Query!
Country [169]
0
0
Hungary
Query!
State/province [169]
0
0
Torokbalint
Query!
Country [170]
0
0
India
Query!
State/province [170]
0
0
Bangalore
Query!
Country [171]
0
0
India
Query!
State/province [171]
0
0
New Delhi
Query!
Country [172]
0
0
India
Query!
State/province [172]
0
0
Pune
Query!
Country [173]
0
0
India
Query!
State/province [173]
0
0
Vellore
Query!
Country [174]
0
0
Indonesia
Query!
State/province [174]
0
0
Jakarta
Query!
Country [175]
0
0
Ireland
Query!
State/province [175]
0
0
Cork
Query!
Country [176]
0
0
Ireland
Query!
State/province [176]
0
0
Dublin
Query!
Country [177]
0
0
Ireland
Query!
State/province [177]
0
0
Galway
Query!
Country [178]
0
0
Israel
Query!
State/province [178]
0
0
Ashkelon
Query!
Country [179]
0
0
Israel
Query!
State/province [179]
0
0
Beer Sheva
Query!
Country [180]
0
0
Israel
Query!
State/province [180]
0
0
Haifa
Query!
Country [181]
0
0
Israel
Query!
State/province [181]
0
0
Holon
Query!
Country [182]
0
0
Israel
Query!
State/province [182]
0
0
Jerusalem
Query!
Country [183]
0
0
Israel
Query!
State/province [183]
0
0
Kfar Saba
Query!
Country [184]
0
0
Israel
Query!
State/province [184]
0
0
Nahariya
Query!
Country [185]
0
0
Israel
Query!
State/province [185]
0
0
Petach Tikva
Query!
Country [186]
0
0
Israel
Query!
State/province [186]
0
0
Ramat-gan
Query!
Country [187]
0
0
Israel
Query!
State/province [187]
0
0
Rehovot
Query!
Country [188]
0
0
Israel
Query!
State/province [188]
0
0
Safed
Query!
Country [189]
0
0
Israel
Query!
State/province [189]
0
0
Tel Aviv
Query!
Country [190]
0
0
Israel
Query!
State/province [190]
0
0
Zerifin
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Ancona
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Avellino
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Aviano
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Bari
Query!
Country [195]
0
0
Italy
Query!
State/province [195]
0
0
Benevento
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Bergamo
Query!
Country [197]
0
0
Italy
Query!
State/province [197]
0
0
Bollate
Query!
Country [198]
0
0
Italy
Query!
State/province [198]
0
0
Bologna
Query!
Country [199]
0
0
Italy
Query!
State/province [199]
0
0
Brescia
Query!
Country [200]
0
0
Italy
Query!
State/province [200]
0
0
Candiolo
Query!
Country [201]
0
0
Italy
Query!
State/province [201]
0
0
Catania
Query!
Country [202]
0
0
Italy
Query!
State/province [202]
0
0
Catanzaro
Query!
Country [203]
0
0
Italy
Query!
State/province [203]
0
0
Cosenza
Query!
Country [204]
0
0
Italy
Query!
State/province [204]
0
0
Cuneo
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Fabriano
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
Feltre - Bl
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
Firenze
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Genova
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
La Spezia
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Lido di Camaiore
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Livorno
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Meldola
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Messina
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Milano
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
Mirano
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
Modena
Query!
Country [217]
0
0
Italy
Query!
State/province [217]
0
0
Napoli
Query!
Country [218]
0
0
Italy
Query!
State/province [218]
0
0
Nuoro
Query!
Country [219]
0
0
Italy
Query!
State/province [219]
0
0
Orbassano
Query!
Country [220]
0
0
Italy
Query!
State/province [220]
0
0
Palermo
Query!
Country [221]
0
0
Italy
Query!
State/province [221]
0
0
Parma
Query!
Country [222]
0
0
Italy
Query!
State/province [222]
0
0
Pavia
Query!
Country [223]
0
0
Italy
Query!
State/province [223]
0
0
Perugia
Query!
Country [224]
0
0
Italy
Query!
State/province [224]
0
0
Pescara
Query!
Country [225]
0
0
Italy
Query!
State/province [225]
0
0
Pisa
Query!
Country [226]
0
0
Italy
Query!
State/province [226]
0
0
Rionero in Vulture
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
Roma
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Salerno
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
San Giovanni Rotondo
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Sassari
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Siena
Query!
Country [232]
0
0
Italy
Query!
State/province [232]
0
0
Sondrio
Query!
Country [233]
0
0
Italy
Query!
State/province [233]
0
0
Taormina
Query!
Country [234]
0
0
Italy
Query!
State/province [234]
0
0
Torino
Query!
Country [235]
0
0
Italy
Query!
State/province [235]
0
0
Trento
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Udine
Query!
Country [237]
0
0
Korea, Republic of
Query!
State/province [237]
0
0
Bundang City
Query!
Country [238]
0
0
Korea, Republic of
Query!
State/province [238]
0
0
Busan
Query!
Country [239]
0
0
Korea, Republic of
Query!
State/province [239]
0
0
Cheonan
Query!
Country [240]
0
0
Korea, Republic of
Query!
State/province [240]
0
0
Daegu
Query!
Country [241]
0
0
Korea, Republic of
Query!
State/province [241]
0
0
Daejeon
Query!
Country [242]
0
0
Korea, Republic of
Query!
State/province [242]
0
0
Gwangju
Query!
Country [243]
0
0
Korea, Republic of
Query!
State/province [243]
0
0
Iksan
Query!
Country [244]
0
0
Korea, Republic of
Query!
State/province [244]
0
0
Incheon
Query!
Country [245]
0
0
Korea, Republic of
Query!
State/province [245]
0
0
Kyunggi-do
Query!
Country [246]
0
0
Korea, Republic of
Query!
State/province [246]
0
0
Pusan
Query!
Country [247]
0
0
Korea, Republic of
Query!
State/province [247]
0
0
Seoul
Query!
Country [248]
0
0
Korea, Republic of
Query!
State/province [248]
0
0
Suwon
Query!
Country [249]
0
0
Latvia
Query!
State/province [249]
0
0
Riga
Query!
Country [250]
0
0
Lithuania
Query!
State/province [250]
0
0
Kaunas
Query!
Country [251]
0
0
Lithuania
Query!
State/province [251]
0
0
Vilnius
Query!
Country [252]
0
0
Malaysia
Query!
State/province [252]
0
0
Kuala Lumpur
Query!
Country [253]
0
0
Mexico
Query!
State/province [253]
0
0
Acapulco
Query!
Country [254]
0
0
Mexico
Query!
State/province [254]
0
0
Chihuahua
Query!
Country [255]
0
0
Mexico
Query!
State/province [255]
0
0
Guadalajara
Query!
Country [256]
0
0
Mexico
Query!
State/province [256]
0
0
Juarez
Query!
Country [257]
0
0
Mexico
Query!
State/province [257]
0
0
Leon
Query!
Country [258]
0
0
Mexico
Query!
State/province [258]
0
0
Matamoros
Query!
Country [259]
0
0
Mexico
Query!
State/province [259]
0
0
Merida
Query!
Country [260]
0
0
Mexico
Query!
State/province [260]
0
0
Mexicali
Query!
Country [261]
0
0
Mexico
Query!
State/province [261]
0
0
Mexico City
Query!
Country [262]
0
0
Mexico
Query!
State/province [262]
0
0
Monterrey
Query!
Country [263]
0
0
Mexico
Query!
State/province [263]
0
0
Obregon
Query!
Country [264]
0
0
Mexico
Query!
State/province [264]
0
0
Puebla
Query!
Country [265]
0
0
Mexico
Query!
State/province [265]
0
0
San Luis Potosi
Query!
Country [266]
0
0
Mexico
Query!
State/province [266]
0
0
Tampico
Query!
Country [267]
0
0
Mexico
Query!
State/province [267]
0
0
Tijuana
Query!
Country [268]
0
0
Mexico
Query!
State/province [268]
0
0
Toluca
Query!
Country [269]
0
0
Mexico
Query!
State/province [269]
0
0
Torreon
Query!
Country [270]
0
0
Mexico
Query!
State/province [270]
0
0
Zapopan
Query!
Country [271]
0
0
Netherlands
Query!
State/province [271]
0
0
's Hertogenbosch
Query!
Country [272]
0
0
Netherlands
Query!
State/province [272]
0
0
Alkmaar
Query!
Country [273]
0
0
Netherlands
Query!
State/province [273]
0
0
Amersfoort
Query!
Country [274]
0
0
Netherlands
Query!
State/province [274]
0
0
Amstelveen
Query!
Country [275]
0
0
Netherlands
Query!
State/province [275]
0
0
Amsterdam
Query!
Country [276]
0
0
Netherlands
Query!
State/province [276]
0
0
Arnhem
Query!
Country [277]
0
0
Netherlands
Query!
State/province [277]
0
0
Assen
Query!
Country [278]
0
0
Netherlands
Query!
State/province [278]
0
0
Beverwijk
Query!
Country [279]
0
0
Netherlands
Query!
State/province [279]
0
0
Boxmeer
Query!
Country [280]
0
0
Netherlands
Query!
State/province [280]
0
0
Breda
Query!
Country [281]
0
0
Netherlands
Query!
State/province [281]
0
0
Capelle Ad Yssel
Query!
Country [282]
0
0
Netherlands
Query!
State/province [282]
0
0
Den Haag
Query!
Country [283]
0
0
Netherlands
Query!
State/province [283]
0
0
Drachten
Query!
Country [284]
0
0
Netherlands
Query!
State/province [284]
0
0
Eindhoven
Query!
Country [285]
0
0
Netherlands
Query!
State/province [285]
0
0
Enschede
Query!
Country [286]
0
0
Netherlands
Query!
State/province [286]
0
0
Groningen
Query!
Country [287]
0
0
Netherlands
Query!
State/province [287]
0
0
Haarlem
Query!
Country [288]
0
0
Netherlands
Query!
State/province [288]
0
0
Harderwijk
Query!
Country [289]
0
0
Netherlands
Query!
State/province [289]
0
0
Heerlen
Query!
Country [290]
0
0
Netherlands
Query!
State/province [290]
0
0
Helmond
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Hengelo
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Maastricht
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Sliedrecht
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Veldhoven
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Venlo
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Vlaardingen
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Vlissingen
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Zaandam
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Zwolle
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Christchurch
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Hamilton
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Palmerston North
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Wellington
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Peru
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Callao
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Peru
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Lima
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Poland
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Gdansk
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Lublin
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Olsztyn
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Poznan
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Warszawa
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Zabrze
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Setubal
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Portugal
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São Martinho do Bispo
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Portugal
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Vila Nova de Gaia
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Romania
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Alba Iulia
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Romania
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Baia Mare
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Bucharest
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Cluj Napoca
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Oradea
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Sibiu
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Suceava
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Romania
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Timisoara
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Russian Federation
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Barnaul
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Kazan
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Krasnodar
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Moscow
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Russian Federation
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Obninsk
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Samara
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Russian Federation
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Smolensk
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Russian Federation
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St Petersburg
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Russian Federation
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Stavropol
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Russian Federation
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Tumen
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Russian Federation
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Ufa
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Russian Federation
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Volgograd
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Riyadh
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Belgrade
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Serbia
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Novi Sad
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Banska Bystrica
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Bratislava
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Kosice
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Nitra
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Slovakia
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Poprad
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Slovenia
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Ljubljana
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Falun
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Goeteborg
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Göteborg
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Linkoeping
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Lund
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Sweden
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Malmoe
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Sweden
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Stockholm
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Sweden
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Uppsala
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Aarau
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Baden
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Chur
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Locarno
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Switzerland
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Switzerland
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Zürich
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taichung
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Tainan
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Taipei
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Taoyuan
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Thailand
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Bangkok
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Shhiye, Ankara
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Uruguay
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Montevideo
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Venezuela
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Caracas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.
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Trial website
https://clinicaltrials.gov/study/NCT00949910
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Trial related presentations / publications
Huang Y, Zhang L, Shi Y, Ma S, Liao M, Bai C, Zhang Q, Wang C, Luo F, Yu S, Qin S, Zhi X, Zhou C. Efficacy of erlotinib in previously treated patients with advanced non-small cell lung cancer: analysis of the Chinese subpopulation in the TRUST study. Jpn J Clin Oncol. 2015 Jun;45(6):569-75. doi: 10.1093/jjco/hyv036. Epub 2015 Apr 7. Heigener DF, Wu YL, van Zandwijk N, Mali P, Horwood K, Reck M. Second-line erlotinib in patients with advanced non-small-cell lung cancer: subgroup analyses from the TRUST study. Lung Cancer. 2011 Nov;74(2):274-9. doi: 10.1016/j.lungcan.2011.02.017. Epub 2011 Mar 24.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00949910
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