Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
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
2 other identifiers
interventional
1,574
22 countries
153
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2006
Longer than P75 for phase_3
153 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 14, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedResults Posted
Study results publicly available
May 24, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedJanuary 25, 2018
January 1, 2018
2.1 years
August 14, 2006
April 27, 2011
January 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
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.
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.
Secondary Outcomes (6)
Overall Survival (OS)
Time to death in months
Objective Response Rate (ORR)
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
Disease Control Rate (DCR)
RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain
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
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea
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
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORErlotinib
2
EXPERIMENTALVandetanib
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed locally advanced or metastatic NSCLC
- Failure of at least one but not more than two prior chemotherapy regimens
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (153)
Research Site
Berkeley, California, United States
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Los Angeles, California, United States
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Santa Rosa, California, United States
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Boynton Beach, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Port Saint Lucie, Florida, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Latham, New York, United States
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Hickory, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Garland, Texas, United States
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Webster, Texas, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Burien, Washington, United States
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Yakima, Washington, United States
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Manuel B. Gonnet, Argentina
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Ramos Mejía, Argentina
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Rosario, Argentina
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Santa Fe, Argentina
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Ashford, Australia
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Bedford Park, Australia
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Chermside, Australia
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Geelong, Australia
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Hornsby, Australia
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Kogarah, Australia
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Malvern, Australia
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Prahran, Australia
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Wodonga, Australia
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Belo Horizonte, Brazil
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Caxias do Sul, Brazil
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Curitiba, Brazil
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Goiânia, Brazil
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Porto Alegre, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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York, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Dalian, China
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Hangzhou, China
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Nanjing, China
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Nanning, China
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Shanghai, China
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Shenyang, China
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Wuhan, China
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Herlev, Denmark
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København Ø, Denmark
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Næstved, Denmark
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Caen, France
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Clermont-Ferrand, France
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Marseille, France
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Paris, France
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Rennes, France
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Vesoul, France
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Göttingen, Germany
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Großhansdorf, Germany
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Hanover, Germany
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Heidelberg, Germany
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Karlsruhe, Germany
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Löwenstein, Germany
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Mainz, Germany
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Mönchengladbach, Germany
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Ulm, Germany
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Hong Kong, Hong Kong
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Bangalore, India
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Karnataka, India
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New Delhi, India
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Pune, India
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Trivandrum, India
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Bandung, Indonesia
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Jakarta, Indonesia
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Solo, Indonesia
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Ancona, Italy
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Avellino, Italy
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Catania, Italy
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Genova, Italy
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Mantova, Italy
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Milan, Italy
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Orbassano, Italy
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Parma, Italy
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Perugia, Italy
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Roma, Italy
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Rozzano, Italy
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Juchitán, Mexico
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Monterrey, Mexico
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Morelia, Mexico
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Puebla City, Mexico
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Saltillo, Mexico
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Zacatecas City, Mexico
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Harderwijk, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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Zwolle, Netherlands
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Bergen, Norway
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Haugesund, Norway
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Kristiansand, Norway
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Oslo, Norway
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Stavanger, Norway
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Tromsø, Norway
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Trondheim, Norway
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Cebu City, Philippines
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Davao City, Philippines
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Manila, Philippines
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Pasay, Philippines
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Quezon City, Philippines
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Seoul, South Korea
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Elche(Alicante), Spain
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Jaén, Spain
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Madrid, Spain
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Mataró(Barcelona), Spain
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Málaga, Spain
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Pamplona, Spain
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Lampang, Thailand
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Songkhla, Thailand
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Birmingham, United Kingdom
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Cambridge, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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Nottingham, United Kingdom
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Sheffield, United Kingdom
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Wolverhampton, United Kingdom
Related Publications (3)
Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD. Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1059-66. doi: 10.1200/JCO.2010.28.5981. Epub 2011 Jan 31.
PMID: 21282542RESULTMishina A, Zhudenkov K, Helmlinger G, Peskov K. A Systematic Comparative Analysis of Tumor Size Models Based on Erlotinib Clinical Data in Advanced NSCLC. CPT Pharmacometrics Syst Pharmacol. 2025 Dec;14(12):1970-1981. doi: 10.1002/psp4.70095. Epub 2025 Aug 11.
PMID: 40785488DERIVEDPlatt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.
PMID: 25881079DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2006
First Posted
August 15, 2006
Study Start
August 1, 2006
Primary Completion
September 1, 2008
Study Completion
November 1, 2016
Last Updated
January 25, 2018
Results First Posted
May 24, 2011
Record last verified: 2018-01