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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00556322




Registration number
NCT00556322
Ethics application status
Date submitted
9/11/2007
Date registered
12/11/2007
Date last updated
23/02/2015

Titles & IDs
Public title
A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Scientific title
An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy
Secondary ID [1] 0 0
BO18602
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 - Alimta or Taxotere
Treatment: Drugs - erlotinib [Tarceva]

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: Alimta or Taxotere
500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)

Treatment: Drugs: erlotinib [Tarceva]
150mg po daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)
Timepoint [1] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months
Primary outcome [2] 0 0
Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)
Timepoint [2] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
Primary outcome [3] 0 0
Probable Percentage of Participants Remaining Alive at 1 Year
Timepoint [3] 0 0
1 Year
Secondary outcome [1] 0 0
Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population
Timepoint [1] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
Secondary outcome [2] 0 0
Duration of OS in EGFR Positive and Negative Population
Timepoint [2] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
Secondary outcome [3] 0 0
Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population
Timepoint [3] 0 0
1 Year
Secondary outcome [4] 0 0
Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)
Timepoint [4] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months
Secondary outcome [5] 0 0
Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)
Timepoint [5] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months
Secondary outcome [6] 0 0
Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months
Timepoint [6] 0 0
6 Months
Secondary outcome [7] 0 0
Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)
Timepoint [7] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Secondary outcome [8] 0 0
PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)
Timepoint [8] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months
Secondary outcome [9] 0 0
Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population
Timepoint [9] 0 0
6 Months
Secondary outcome [10] 0 0
Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST
Timepoint [10] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months
Secondary outcome [11] 0 0
Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)
Timepoint [11] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Secondary outcome [12] 0 0
Time to Deterioration in Quality of Life Using FACT-L
Timepoint [12] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Secondary outcome [13] 0 0
Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L
Timepoint [13] 0 0
6 Months
Secondary outcome [14] 0 0
Percentage of Participants With Symptomatic Progression Using FACT-L
Timepoint [14] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Secondary outcome [15] 0 0
Time to Symptomatic Progression Using FACT-L
Timepoint [15] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Secondary outcome [16] 0 0
Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L
Timepoint [16] 0 0
6 Months
Secondary outcome [17] 0 0
Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)
Timepoint [17] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Secondary outcome [18] 0 0
Time to Deterioration in the TOI
Timepoint [18] 0 0
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Secondary outcome [19] 0 0
Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L
Timepoint [19] 0 0
6 Months

Eligibility
Key inclusion criteria
* adult patients >=18 years of age;
* histologically documented, locally advanced or recurrent or metastatic NSCLC;
* measurable disease;
* disease progression during 1-4 cycles of platinum-based chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* any other malignancies within the last 5 years;
* unstable systemic disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
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
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
424
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- East Bentleigh
Recruitment hospital [5] 0 0
- Fitzroy
Recruitment hospital [6] 0 0
- Geelong
Recruitment hospital [7] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
5041 - Adelaide
Recruitment postcode(s) [4] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Klagenfurt
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Antwerpen
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Chile
State/province [8] 0 0
Santiago
Country [9] 0 0
China
State/province [9] 0 0
Beijing
Country [10] 0 0
China
State/province [10] 0 0
Guangzhou
Country [11] 0 0
China
State/province [11] 0 0
Shanghai
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Ceské Budejovice
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Olomouc
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Plzen
Country [15] 0 0
Denmark
State/province [15] 0 0
Herlev
Country [16] 0 0
Denmark
State/province [16] 0 0
Odense
Country [17] 0 0
France
State/province [17] 0 0
Bayonne
Country [18] 0 0
France
State/province [18] 0 0
Brest
Country [19] 0 0
France
State/province [19] 0 0
Clermont-ferrand
Country [20] 0 0
France
State/province [20] 0 0
Dijon
Country [21] 0 0
France
State/province [21] 0 0
Le Mans
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Limoges
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
PAU
Country [26] 0 0
France
State/province [26] 0 0
Toulouse
Country [27] 0 0
France
State/province [27] 0 0
Vandoeuvre-les-nancy
Country [28] 0 0
Germany
State/province [28] 0 0
Bad Berka
Country [29] 0 0
Germany
State/province [29] 0 0
Bochum
Country [30] 0 0
Germany
State/province [30] 0 0
Halle (Saale)
Country [31] 0 0
Germany
State/province [31] 0 0
Herne
Country [32] 0 0
Germany
State/province [32] 0 0
Neuruppin
Country [33] 0 0
Germany
State/province [33] 0 0
Villingen-Schwenningen
Country [34] 0 0
Greece
State/province [34] 0 0
Athens
Country [35] 0 0
Greece
State/province [35] 0 0
Heraklion
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Deszk
Country [38] 0 0
Hungary
State/province [38] 0 0
Nyíregyháza
Country [39] 0 0
Hungary
State/province [39] 0 0
Pecs
Country [40] 0 0
Hungary
State/province [40] 0 0
Szombathely
Country [41] 0 0
Hungary
State/province [41] 0 0
Torokbalint
Country [42] 0 0
Italy
State/province [42] 0 0
Emilia-Romagna
Country [43] 0 0
Italy
State/province [43] 0 0
Lazio
Country [44] 0 0
Italy
State/province [44] 0 0
Marche
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Daegu
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Suwon
Country [48] 0 0
Lithuania
State/province [48] 0 0
Kaunas
Country [49] 0 0
Lithuania
State/province [49] 0 0
Klaipeda
Country [50] 0 0
Lithuania
State/province [50] 0 0
Vilnius
Country [51] 0 0
Malaysia
State/province [51] 0 0
Kuala Lumpur
Country [52] 0 0
Malaysia
State/province [52] 0 0
Penang
Country [53] 0 0
New Zealand
State/province [53] 0 0
Auckland
Country [54] 0 0
New Zealand
State/province [54] 0 0
Christchurch
Country [55] 0 0
Poland
State/province [55] 0 0
Lodz
Country [56] 0 0
Poland
State/province [56] 0 0
Otwock
Country [57] 0 0
Romania
State/province [57] 0 0
Bucuresti
Country [58] 0 0
Romania
State/province [58] 0 0
Cluj Napoca
Country [59] 0 0
Romania
State/province [59] 0 0
Iasi
Country [60] 0 0
Romania
State/province [60] 0 0
Timisoara
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Arkhangelsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Balashikha
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Chelyabinsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Kazan
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Kirov
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Krasnodar
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Kuzmolovo
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Moscow
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Nizhny Novgorod
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Perm
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Smolensk
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Soshi
Country [73] 0 0
Russian Federation
State/province [73] 0 0
St Petersburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Yaroslavl
Country [75] 0 0
Slovakia
State/province [75] 0 0
Banska Bystrica
Country [76] 0 0
Slovakia
State/province [76] 0 0
Bratislava
Country [77] 0 0
Slovakia
State/province [77] 0 0
Nitra
Country [78] 0 0
Slovakia
State/province [78] 0 0
Poprad
Country [79] 0 0
Slovenia
State/province [79] 0 0
Golnik
Country [80] 0 0
Slovenia
State/province [80] 0 0
Ljubljana
Country [81] 0 0
Slovenia
State/province [81] 0 0
Maribor
Country [82] 0 0
South Africa
State/province [82] 0 0
Durban
Country [83] 0 0
South Africa
State/province [83] 0 0
Johannesburg
Country [84] 0 0
South Africa
State/province [84] 0 0
Pretoria
Country [85] 0 0
Spain
State/province [85] 0 0
Asturias
Country [86] 0 0
Spain
State/province [86] 0 0
Cantabria
Country [87] 0 0
Spain
State/province [87] 0 0
La Coruña
Country [88] 0 0
Spain
State/province [88] 0 0
Zaragoza
Country [89] 0 0
Ukraine
State/province [89] 0 0
Kharkov
Country [90] 0 0
Ukraine
State/province [90] 0 0
Uzhgorod
Country [91] 0 0
Ukraine
State/province [91] 0 0
Zaporozhye
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Chelmsford
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Dundee
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Leicester
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Plymouth
Country [96] 0 0
Venezuela
State/province [96] 0 0
Caracas

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT00556322