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

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ClinicalTrials.gov Identifier: NCT00364351

Recruitment Status : Completed

First Posted : August 15, 2006

Results First Posted : May 24, 2011

Last Update Posted : January 25, 2018

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Sponsor:

Information provided by (Responsible Party):

Sanofi ( Genzyme, a Sanofi Company )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Non Small Cell Lung Cancer
Interventions	Drug: Vandetanib Drug: Erlotinib
Enrollment	1574

Participant Flow

Recruitment Details	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	1574 patients were enrolled/screened to the study but only 1240 patients were entered treatment/randomized.


Arm/Group Title	Vandetanib	Erlotinib
Arm/Group Description	Vandetanib 300 mg tablet taken once...	Erlotinib 150 mg tablet taken once ...
Arm/Group Description	Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib	Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib
Period Title: Overall Study
Started	623 ^[1]	617 ^[1]
Completed	31 ^[2]	34 ^[2]
Not Completed	592	583
Reason Not Completed
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 date 26 Sep 2008.

Baseline Characteristics

Arm/Group Title		Vandetanib	Erlotinib	Total
Arm/Group Description		Vandetanib 300 mg	Erlotinib	Total of all reporting groups
Arm/Group Description		Vandetanib 300 mg	Erlotinib	Total of all reporting groups
Overall Number of Baseline Participants		623	617	1240
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Full Range) Unit of measure: Years
	Number Analyzed	623 participants	617 participants	1240 participants
		60 (26 to 92)	61 (26 to 85)	60 (26 to 92)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	623 participants	617 participants	1240 participants
	Female	242 38.8%	224 36.3%	466 37.6%
	Male	381 61.2%	393 63.7%	774 62.4%

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival (PFS)
Description	Median time (in weeks) from randomisation until objective disease prog...
Description	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.
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.

Outcome Measure Data