ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer - Study Results

ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer (ZODIAC)

This study is ongoing, but not recruiting participants.

Study NCT00312377 Information provided by AstraZeneca

First Received on April 6, 2006. Last Updated on April 27, 2011 History of Changes

Results First Received: April 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Non-small Cell Lung Cancer Lung Cancer
Interventions:	Drug: Docetaxel Drug: Vandetanib

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 08 May 2006, last patient enrolled 14 March 2008, cut off date 22 August 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Vandetanib 100 mg Plus Docetaxel	Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel	Placebo plus docetaxel

Participant Flow: Overall Study

	Vandetanib 100 mg Plus Docetaxel	Placebo Plus Docetaxel
STARTED	694 ^[1]	697 ^[1]
COMPLETED	50 ^[2]	29 ^[2]
NOT COMPLETED	644	668
Death	400	414
Withdrawal by Subject	22	30
Lost to Follow-up	9	12
Other	1	2
Randomised but never received treatment	6	6
Discontinue treatment survival follow up	206	204

[1]	randomised patients
[2]	ongoing study treatment at data cut-off

Baseline Characteristics

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Reporting Groups

	Description
Vandetanib 100 mg Plus Docetaxel	Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel	Placebo plus docetaxel

Baseline Measures

	Vandetanib 100 mg Plus Docetaxel	Placebo Plus Docetaxel	Total
Number of Participants [units: participants]	694	697	1391
Age [units: years] Mean ( Full Range )	58.5 ( 28 to 82 )	58.4 ( 20 to 82 )	58.45 ( 20 to 82 )
Gender [units: Participants]
Female	497	473	970
Male	197	224	421

Outcome Measures

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1. Primary:

Progression-Free Survival (PFS) in the Overall Population [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective disease progression ]

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2. Primary:

Progression-Free Survival (PFS) in the Female Population [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective disease progression ]

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3. Secondary:

Overall Survival (OS) in the Overall Population [ Time Frame: Time to death in months ]

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4. Secondary:

Overall Survival (OS) in the Female Population [ Time Frame: Time to death in months ]

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5. Secondary:

Objective Response Rate (ORR) [ Time Frame: Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]

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6. Secondary:

Disease Control Rate (DCR) [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]

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7. Secondary:

Duration of Response (DoR) [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]

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8. Secondary:

Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Lung Cancer Subscale (LCS) [ Time Frame: FACT-L questionnaires are to be administered every 3 weeks after randomisation ]

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9. Secondary:

Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI) [ Time Frame: FACT-L questionnaires are to be administered every 3 weeks after randomisation ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com

No publications provided by AstraZeneca

Publications automatically indexed to this study:

Herbst RS, Sun Y, Eberhardt WE, Germonpré P, Saijo N, Zhou C, Wang J, Li L, Kabbinavar F, Ichinose Y, Qin S, Zhang L, Biesma B, Heymach JV, Langmuir P, Kennedy SJ, Tada H, Johnson BE. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2010 Jul;11(7):619-26.

ClinicalTrials.gov Identifier:	NCT00312377 History of Changes
Other Study ID Numbers:	D4200C00032, 6474IL/0032
Study First Received:	April 6, 2006
Results First Received:	April 27, 2011
Last Updated:	April 27, 2011
Health Authority:	United States: Food and Drug Administration