Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
January 24, 2018 updated by: Genzyme, a Sanofi Company
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1574
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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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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Sao Paulo, Brazil
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British Columbia
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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Ontario
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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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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada
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Quebec
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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 Cedex 12, France
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RENNES Cedex 9, France
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Vesoul Cedex, France
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Großhansdorf, Germany
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Göttingen, Germany
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Hannover, 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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Milano, 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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Seoul, Korea, Republic of
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Juchitan, Mexico
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Monterrey, Mexico
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Morelia, Mexico
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Puebla, Mexico
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Saltillo, Mexico
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Zacatecas, 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 City, Philippines
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Quezon City, Philippines
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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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Tao-Yuan, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Lampang, Thailand
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Songkla, 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
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California
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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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Florida
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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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Kansas
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Wichita, Kansas, United States
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Kentucky
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisiana
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Metairie, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Missouri
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Columbia, Missouri, United States
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Saint Louis, Missouri, United States
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New York
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Latham, New York, United States
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North Carolina
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Hickory, North Carolina, United States
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Ohio
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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South Carolina
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Greenville, South Carolina, United States
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Tennessee
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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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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Virginia
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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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Washington
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Burien, Washington, United States
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Yakima, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed locally advanced or metastatic NSCLC
- Failure of at least one but not more than two prior chemotherapy regimens
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 2
Vandetanib
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once daily oral tablet
Other Names:
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Active Comparator: 1
Erlotinib
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oral dose
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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. |
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Survival (OS)
Time Frame: Time to death in months
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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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Time to death in months
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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
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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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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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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
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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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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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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
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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. |
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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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
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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. |
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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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
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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. |
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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Platt 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
August 14, 2006
First Submitted That Met QC Criteria
August 14, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 24, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- D4200C00057
- EUDRACT No. 2006-000259-16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.