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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
Scientific title
An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2004-000564-28
Secondary ID [2] 0 0
MO18109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Timepoint [1] 0 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
Secondary outcome [1] 0 0
Percentage of Participants With Disease Control According to RECIST
Timepoint [1] 0 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
Secondary outcome [2] 0 0
Percentage of Participants by Best Overall Response According to RECIST
Timepoint [2] 0 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
Secondary outcome [3] 0 0
Percentage of Participants With Death or Disease Progression According to RECIST
Timepoint [3] 0 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
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) According to RECIST
Timepoint [4] 0 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
Secondary outcome [5] 0 0
Percentage of Participants Who Died
Timepoint [5] 0 0
Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
6586
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Chermside
Recruitment hospital [4] 0 0
- Frankston
Recruitment hospital [5] 0 0
- Fremantle
Recruitment hospital [6] 0 0
- Geelong
Recruitment hospital [7] 0 0
- Kurralta Park
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Melbourne
Recruitment hospital [10] 0 0
- Perth
Recruitment hospital [11] 0 0
- St. Leonards
Recruitment hospital [12] 0 0
- Sydney
Recruitment hospital [13] 0 0
- Tugun
Recruitment hospital [14] 0 0
- Waratah
Recruitment hospital [15] 0 0
- Wodonga
Recruitment hospital [16] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment postcode(s) [9] 0 0
3002 - Melbourne
Recruitment postcode(s) [10] 0 0
3084 - Melbourne
Recruitment postcode(s) [11] 0 0
6009 - Perth
Recruitment postcode(s) [12] 0 0
2065 - St. Leonards
Recruitment postcode(s) [13] 0 0
2031 - Sydney
Recruitment postcode(s) [14] 0 0
2217 - Sydney
Recruitment postcode(s) [15] 0 0
4224 - Tugun
Recruitment postcode(s) [16] 0 0
2298 - Waratah
Recruitment postcode(s) [17] 0 0
3690 - Wodonga
Recruitment postcode(s) [18] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Albania
State/province [1] 0 0
Tirana
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Argentina
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La Plata
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Argentina
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Salta
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Argentina
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Santa Fe
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Austria
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Bludesch
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Austria
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Grimmenstein
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Austria
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Innsbruck
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Austria
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Klagenfurt
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Austria
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Kufstein
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Austria
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Leoben
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Austria
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Linz
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Austria
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Natters
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Oberpullendorf
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Austria
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Salzburg
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Austria
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Wels
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Austria
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Wien
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Zams
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Belgium
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Aalst
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Arlon
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Baudour
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Blankenberge
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Borgerhout
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Boussu
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Belgium
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Brasschaat
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Belgium
State/province [28] 0 0
Bruxelles
Country [29] 0 0
Belgium
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Charleroi
Country [30] 0 0
Belgium
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Edegem
Country [31] 0 0
Belgium
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Genk
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Belgium
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Gent
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Belgium
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Gilly
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Belgium
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Godinne
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Belgium
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Gosselies
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Belgium
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Haine-saint-paul
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Belgium
State/province [37] 0 0
Hasselt
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Belgium
State/province [38] 0 0
Kortrijk
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Belgium
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Libramont
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Liege
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Mons
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Namur
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State/province [44] 0 0
Ottignies
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Oudenaarde
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State/province [46] 0 0
Roeselare
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State/province [47] 0 0
Sint-niklaas
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Belgium
State/province [48] 0 0
Tielt
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Belgium
State/province [49] 0 0
Tournai
Country [50] 0 0
Belgium
State/province [50] 0 0
Turnhout
Country [51] 0 0
Belgium
State/province [51] 0 0
Wilrijk
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Bosnia and Herzegovina
State/province [52] 0 0
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State/province [53] 0 0
Sarajevo
Country [54] 0 0
Brazil
State/province [54] 0 0
Belo Horizonte
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Brazil
State/province [55] 0 0
Brasilia
Country [56] 0 0
Brazil
State/province [56] 0 0
Campinas
Country [57] 0 0
Brazil
State/province [57] 0 0
Caxias do Sul
Country [58] 0 0
Brazil
State/province [58] 0 0
Curitiba
Country [59] 0 0
Brazil
State/province [59] 0 0
Fortaleza
Country [60] 0 0
Brazil
State/province [60] 0 0
Ijui
Country [61] 0 0
Brazil
State/province [61] 0 0
Jaú
Country [62] 0 0
Brazil
State/province [62] 0 0
Joao Pessoa
Country [63] 0 0
Brazil
State/province [63] 0 0
Porto Alegre
Country [64] 0 0
Brazil
State/province [64] 0 0
Recife
Country [65] 0 0
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State/province [65] 0 0
Ribeirao Preto
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Rio de Janeiro
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Salvador
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State/province [68] 0 0
Santos
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State/province [69] 0 0
Sao Paulo
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Sorocaba
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Plovdiv
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Sofia
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Varna
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Santiago
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Guangzhou
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Hangzhou
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Harbin
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Nanjing
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Shanghai
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Tianjin
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Wuhan
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Bogota
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Brno
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Plzen
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Praha
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Cairo
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Giza
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Tallin
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Helsinki
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Joensuu
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State/province [101] 0 0
Kuopio
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Oulu
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Pori
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State/province [104] 0 0
Tampere
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Vaasa
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Augsburg
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Celle
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Dortmund
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Frankfurt Am Main
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Frankfurt
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Freiburg
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Gauting
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Germany
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Gerlingen
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Germany
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Giessen
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Germany
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Grosshansdorf
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Germany
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Halle (saale)
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Germany
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Hamburg
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Germany
State/province [127] 0 0
Heidelberg
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Germany
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Herne
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Homburg/Saar
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Germany
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Kassel
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Germany
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Koblenz
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Germany
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Köln
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Germany
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Leipzig
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Germany
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Leverkusen
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Germany
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Lostau
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Germany
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Löwenstein
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Germany
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Lübeck
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Minden
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Germany
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Muenchen
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Germany
State/province [142] 0 0
Mönchengladbach
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Germany
State/province [143] 0 0
München
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Germany
State/province [144] 0 0
Neuruppin
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Germany
State/province [145] 0 0
Nürnberg
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Germany
State/province [146] 0 0
Oldenburg
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Germany
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Osnabrück
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Germany
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Rostock
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Germany
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Saarbruecken
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Germany
State/province [150] 0 0
Trier
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Germany
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Ulm
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Germany
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Wangen
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State/province [154] 0 0
Wuerselen
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Germany
State/province [155] 0 0
Wuppertal
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Athens
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Haidari
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Heraklion
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Hong Kong
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Hungary
State/province [163] 0 0
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Nyíregyháza
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Israel
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Israel
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Israel
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Petach Tikva
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Israel
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Ramat-gan
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Israel
State/province [187] 0 0
Rehovot
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Israel
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Israel
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Israel
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Ancona
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Avellino
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Aviano
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Bari
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Benevento
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Italy
State/province [196] 0 0
Bergamo
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Bollate
Country [198] 0 0
Italy
State/province [198] 0 0
Bologna
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Italy
State/province [199] 0 0
Brescia
Country [200] 0 0
Italy
State/province [200] 0 0
Candiolo
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Italy
State/province [201] 0 0
Catania
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Italy
State/province [202] 0 0
Catanzaro
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Italy
State/province [203] 0 0
Cosenza
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Italy
State/province [204] 0 0
Cuneo
Country [205] 0 0
Italy
State/province [205] 0 0
Fabriano
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Italy
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Feltre - Bl
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Italy
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Firenze
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Italy
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Genova
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Italy
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La Spezia
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Italy
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Lido di Camaiore
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Italy
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Livorno
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Italy
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Meldola
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Italy
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Messina
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Italy
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Milano
Country [215] 0 0
Italy
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Mirano
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Italy
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Modena
Country [217] 0 0
Italy
State/province [217] 0 0
Napoli
Country [218] 0 0
Italy
State/province [218] 0 0
Nuoro
Country [219] 0 0
Italy
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Orbassano
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Italy
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Palermo
Country [221] 0 0
Italy
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Caracas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00949910
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00949910