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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00949910




Registration number
NCT00949910
Ethics application status
Date submitted
15/04/2009
Date registered
30/07/2009
Date last updated
4/10/2016

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
Non-Small Cell Lung Cancer 0 0
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
Treatment: Drugs - Erlotinib
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.

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.

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.

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.

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) - 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.
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
Primary outcome [2] 0 0
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) - 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.
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
Primary outcome [3] 0 0
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) - 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.
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 [1] 0 0
Percentage of Participants With Disease Control According to RECIST - 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.
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 - 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.
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 - 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.
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 - 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.
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 - The percentage of participants (in nearest integer) who died from any cause was reported.
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) - 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.
Timepoint [6] 0 0
Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Secondary outcome [7] 0 0
Percentage of Participants With Disease Control According to RECIST - 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.
Timepoint [7] 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 [8] 0 0
Percentage of Participants by Best Overall Response According to RECIST - 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.
Timepoint [8] 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 [9] 0 0
Percentage of Participants With Death or Disease Progression According to RECIST - 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.
Timepoint [9] 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 [10] 0 0
Progression-Free Survival (PFS) According to RECIST - 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.
Timepoint [10] 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 [11] 0 0
Percentage of Participants Who Died - The percentage of participants (in nearest integer) who died from any cause was reported.
Timepoint [11] 0 0
Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Secondary outcome [12] 0 0
Overall Survival (OS) - 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.
Timepoint [12] 0 0
Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Secondary outcome [13] 0 0
Percentage of Participants With Disease Control According to RECIST - 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.
Timepoint [13] 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 [14] 0 0
Percentage of Participants by Best Overall Response According to RECIST - 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.
Timepoint [14] 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 [15] 0 0
Percentage of Participants With Death or Disease Progression According to RECIST - 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.
Timepoint [15] 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 [16] 0 0
Progression-Free Survival (PFS) According to RECIST - 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.
Timepoint [16] 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 [17] 0 0
Percentage of Participants Who Died - The percentage of participants (in nearest integer) who died from any cause was reported.
Timepoint [17] 0 0
Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Secondary outcome [18] 0 0
Overall Survival (OS) - 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.
Timepoint [18] 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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Córdoba
Country [4] 0 0
Argentina
State/province [4] 0 0
La Plata
Country [5] 0 0
Argentina
State/province [5] 0 0
Salta
Country [6] 0 0
Argentina
State/province [6] 0 0
Santa Fe
Country [7] 0 0
Austria
State/province [7] 0 0
Bludesch
Country [8] 0 0
Austria
State/province [8] 0 0
Grimmenstein
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Austria
State/province [10] 0 0
Klagenfurt
Country [11] 0 0
Austria
State/province [11] 0 0
Kufstein
Country [12] 0 0
Austria
State/province [12] 0 0
Leoben
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Natters
Country [15] 0 0
Austria
State/province [15] 0 0
Oberpullendorf
Country [16] 0 0
Austria
State/province [16] 0 0
Salzburg
Country [17] 0 0
Austria
State/province [17] 0 0
Wels
Country [18] 0 0
Austria
State/province [18] 0 0
Wien
Country [19] 0 0
Austria
State/province [19] 0 0
Zams
Country [20] 0 0
Belgium
State/province [20] 0 0
Aalst
Country [21] 0 0
Belgium
State/province [21] 0 0
Antwerpen
Country [22] 0 0
Belgium
State/province [22] 0 0
Arlon
Country [23] 0 0
Belgium
State/province [23] 0 0
Baudour
Country [24] 0 0
Belgium
State/province [24] 0 0
Blankenberge
Country [25] 0 0
Belgium
State/province [25] 0 0
Borgerhout
Country [26] 0 0
Belgium
State/province [26] 0 0
Boussu
Country [27] 0 0
Belgium
State/province [27] 0 0
Brasschaat
Country [28] 0 0
Belgium
State/province [28] 0 0
Bruxelles
Country [29] 0 0
Belgium
State/province [29] 0 0
Charleroi
Country [30] 0 0
Belgium
State/province [30] 0 0
Edegem
Country [31] 0 0
Belgium
State/province [31] 0 0
Genk
Country [32] 0 0
Belgium
State/province [32] 0 0
Gent
Country [33] 0 0
Belgium
State/province [33] 0 0
Gilly
Country [34] 0 0
Belgium
State/province [34] 0 0
Godinne
Country [35] 0 0
Belgium
State/province [35] 0 0
Gosselies
Country [36] 0 0
Belgium
State/province [36] 0 0
Haine-saint-paul
Country [37] 0 0
Belgium
State/province [37] 0 0
Hasselt
Country [38] 0 0
Belgium
State/province [38] 0 0
Kortrijk
Country [39] 0 0
Belgium
State/province [39] 0 0
Libramont
Country [40] 0 0
Belgium
State/province [40] 0 0
Liege
Country [41] 0 0
Belgium
State/province [41] 0 0
Mons
Country [42] 0 0
Belgium
State/province [42] 0 0
Namur
Country [43] 0 0
Belgium
State/province [43] 0 0
Oostende
Country [44] 0 0
Belgium
State/province [44] 0 0
Ottignies
Country [45] 0 0
Belgium
State/province [45] 0 0
Oudenaarde
Country [46] 0 0
Belgium
State/province [46] 0 0
Roeselare
Country [47] 0 0
Belgium
State/province [47] 0 0
Sint-niklaas
Country [48] 0 0
Belgium
State/province [48] 0 0
Tielt
Country [49] 0 0
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
Country [52] 0 0
Bosnia and Herzegovina
State/province [52] 0 0
Banja Luka
Country [53] 0 0
Bosnia and Herzegovina
State/province [53] 0 0
Sarajevo
Country [54] 0 0
Brazil
State/province [54] 0 0
Belo Horizonte
Country [55] 0 0
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
Brazil
State/province [65] 0 0
Ribeirao Preto
Country [66] 0 0
Brazil
State/province [66] 0 0
Rio de Janeiro
Country [67] 0 0
Brazil
State/province [67] 0 0
Salvador
Country [68] 0 0
Brazil
State/province [68] 0 0
Santos
Country [69] 0 0
Brazil
State/province [69] 0 0
Sao Paulo
Country [70] 0 0
Brazil
State/province [70] 0 0
Sorocaba
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Plovdiv
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Sofia
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Varna
Country [74] 0 0
Chile
State/province [74] 0 0
Santiago
Country [75] 0 0
China
State/province [75] 0 0
Beijing
Country [76] 0 0
China
State/province [76] 0 0
Chengdu
Country [77] 0 0
China
State/province [77] 0 0
Guangzhou
Country [78] 0 0
China
State/province [78] 0 0
Hangzhou
Country [79] 0 0
China
State/province [79] 0 0
Harbin
Country [80] 0 0
China
State/province [80] 0 0
Nanjing
Country [81] 0 0
China
State/province [81] 0 0
Shanghai
Country [82] 0 0
China
State/province [82] 0 0
Tianjin
Country [83] 0 0
China
State/province [83] 0 0
Wuhan
Country [84] 0 0
Colombia
State/province [84] 0 0
Bogota
Country [85] 0 0
Colombia
State/province [85] 0 0
Cali
Country [86] 0 0
Croatia
State/province [86] 0 0
Zagreb
Country [87] 0 0
Czech Republic
State/province [87] 0 0
Brno
Country [88] 0 0
Czech Republic
State/province [88] 0 0
Hradec Kralove
Country [89] 0 0
Czech Republic
State/province [89] 0 0
Olomouc
Country [90] 0 0
Czech Republic
State/province [90] 0 0
Plzen
Country [91] 0 0
Czech Republic
State/province [91] 0 0
Praha
Country [92] 0 0
Ecuador
State/province [92] 0 0
Guayaquil
Country [93] 0 0
Ecuador
State/province [93] 0 0
Quito
Country [94] 0 0
Egypt
State/province [94] 0 0
Cairo
Country [95] 0 0
Egypt
State/province [95] 0 0
Giza
Country [96] 0 0
Estonia
State/province [96] 0 0
Tallin
Country [97] 0 0
Estonia
State/province [97] 0 0
Tartu
Country [98] 0 0
Finland
State/province [98] 0 0
Haemeenlinna
Country [99] 0 0
Finland
State/province [99] 0 0
Helsinki
Country [100] 0 0
Finland
State/province [100] 0 0
Joensuu
Country [101] 0 0
Finland
State/province [101] 0 0
Kuopio
Country [102] 0 0
Finland
State/province [102] 0 0
Oulu
Country [103] 0 0
Finland
State/province [103] 0 0
Pori
Country [104] 0 0
Finland
State/province [104] 0 0
Tampere
Country [105] 0 0
Finland
State/province [105] 0 0
Turku
Country [106] 0 0
Finland
State/province [106] 0 0
Vaasa
Country [107] 0 0
Germany
State/province [107] 0 0
Amberg
Country [108] 0 0
Germany
State/province [108] 0 0
Augsburg
Country [109] 0 0
Germany
State/province [109] 0 0
Aurich
Country [110] 0 0
Germany
State/province [110] 0 0
Bad Berka
Country [111] 0 0
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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/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
Other publications