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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/NCT00364351
Registration number
NCT00364351
Ethics application status
Date submitted
14/08/2006
Date registered
15/08/2006
Date last updated
25/01/2018
Titles & IDs
Public title
Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
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Scientific title
A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy
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Secondary ID [1]
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EUDRACT No. 2006-000259-16
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Secondary ID [2]
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D4200C00057
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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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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
0
0
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0
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Lung - Non small cell
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Cancer
0
0
0
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 - Vandetanib
Treatment: Drugs - Erlotinib
Active Comparator: 1 - Erlotinib
Experimental: 2 - Vandetanib
Treatment: Drugs: Vandetanib
once daily oral tablet
Treatment: Drugs: Erlotinib
oral dose
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Intervention code [1]
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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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Progression-Free Survival (PFS)
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Assessment method [1]
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Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.
Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
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Timepoint [1]
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progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
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Timepoint [1]
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Time to death in months
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.
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Timepoint [2]
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RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.
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Timepoint [3]
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RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression
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Secondary outcome [4]
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Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain
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Assessment method [4]
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Pain was assessed as the average score of two items: Question 9 ("Have you had pain") and 19 ("Did pain interfere with your daily activities") of the QLQ-C30.
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days.
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Timepoint [4]
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Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
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Secondary outcome [5]
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Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea
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Assessment method [5]
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Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 ("Were you short of breath") and Question 3 of the QLQ-C30 ("Were you short of breath when you rested"), Questions 4 ("Were you short of breath when you walked") and 5 ("Were you short of breath when you climbed stairs") of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days.
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Timepoint [5]
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Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
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Secondary outcome [6]
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Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough
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Assessment method [6]
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Cough was assessed using Question 1 ("How much did you cough") of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days.
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Timepoint [6]
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Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
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Eligibility
Key inclusion criteria
- Confirmed locally advanced or metastatic NSCLC
- Failure of at least one but not more than two 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
- Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent),
sorafenib (Nexavar)
- Chemotherapy or other type of anti cancer therapy within 4 weeks of study start
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/08/2006
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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
1/11/2016
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Sample size
Target
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Accrual to date
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Final
1574
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Ashford
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Research Site - Bedford Park
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Recruitment postcode(s) [1]
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- Ashford
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- Bedford Park
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- Chermside
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- Geelong
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- Hornsby
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- Kogarah
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Recruitment postcode(s) [7]
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- Malvern
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- Prahran
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Recruitment postcode(s) [9]
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- Wodonga
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Recruitment outside Australia
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Ohio
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Rosario
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Santa Fe
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Taichung
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Country [110]
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0
Taiwan
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State/province [110]
0
0
Tainan
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Country [111]
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0
Taiwan
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State/province [111]
0
0
Taipei
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Country [112]
0
0
Taiwan
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State/province [112]
0
0
Tao-Yuan
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Country [113]
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0
Thailand
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State/province [113]
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0
Bangkok
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Country [114]
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0
Thailand
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State/province [114]
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0
Chiang Mai
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Country [115]
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0
Thailand
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State/province [115]
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0
Lampang
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Country [116]
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0
Thailand
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State/province [116]
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0
Songkla
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Country [117]
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0
United Kingdom
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State/province [117]
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0
Birmingham
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Country [118]
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0
United Kingdom
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State/province [118]
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0
Cambridge
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Country [119]
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0
United Kingdom
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State/province [119]
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0
Leicester
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Country [120]
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United Kingdom
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State/province [120]
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0
Liverpool
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Country [121]
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United Kingdom
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State/province [121]
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0
Nottingham
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Country [122]
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United Kingdom
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State/province [122]
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0
Sheffield
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Country [123]
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0
United Kingdom
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State/province [123]
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0
Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genzyme, a Sanofi Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung
Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy,
Erlotinib
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00364351
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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0
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00364351
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