Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00364351
First received: August 14, 2006
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Drug: Vandetanib
Drug: Erlotinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled 24 August 2006, last patient enrolled 31 October 2007, cut off date 26 September 2008. 1574 patients were enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1574 patients were enrolled/screened to the study but only 1240 patients were entered treatment/randomized.

Reporting Groups
  Description
Vandetanib Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib
Erlotinib Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib

Participant Flow:   Overall Study
    Vandetanib     Erlotinib  
STARTED     623 [1]   617 [1]
COMPLETED     31 [2]   34 [2]
NOT COMPLETED     592     583  
Adverse Event                 90                 44  
Condition under investigation worsened                 469                 497  
Prohibited concomitant medication                 0                 2  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 30                 29  
Incorrect enrollment                 1                 1  
Sponsor decision                 1                 0  
Poor treatment compliance                 0                 3  
Investigator error                 0                 2  
Patient could not travel to site                 0                 1  
Randomised treatment not started                 0                 3  
[1] randomised patients
[2] ongoing study treatment at data cut-off



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vandetanib Vandetanib 300 mg
Erlotinib Erlotinib
Total Total of all reporting groups

Baseline Measures
    Vandetanib     Erlotinib     Total  
Number of Participants  
[units: participants]
  623     617     1240  
Age  
[units: years]
Mean ( Full Range )
  60  
  ( 26 to 92 )  
  61  
  ( 26 to 85 )  
  60  
  ( 26 to 92 )  
Gender  
[units: Participants]
     
Female     242     224     466  
Male     381     393     774  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: 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. ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Time to death in months ]

3.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: 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 ]

4.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression ]

5.  Secondary:   Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain   [ Time Frame: 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 ]

6.  Secondary:   Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea   [ Time Frame: 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 ]

7.  Secondary:   Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough   [ Time Frame: 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00364351     History of Changes
Other Study ID Numbers: D4200C00057, EUDRACT No. 2006-000259-16
Study First Received: August 14, 2006
Results First Received: April 27, 2011
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration