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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/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
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that
of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC
experiencing disease progression after failure of platinum-based chemotherapy.Eligible
patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either
Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on
study treatment is until disease progression ,and the target sample size is 500+ individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00556322
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