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

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: ZD6474 (Drug); Erlotinib (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
ZD6474 Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Cancer Support Network, Phone: 1-866-992-9276, Email: information.center@astrazeneca.com

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

Official title: 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

Study design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Demonstrate an improvement in Progression Free Survival for ZD6474 compared with erlotinib in patients with locally advanced or metastatic NSCLC after failure of at least one but no more than two, prior chemotherapy regimes.

Secondary outcome: To demonstrate an overall improvement in survival for ZD6474 compared with erlotinib

Minimum age: 18 Years. Gender(s): Both.

Criteria:

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

AstraZeneca Cancer Support Network, Phone: 1-866-992-9276, Email: information.center@astrazeneca.com

Research Site, Birmingham, Alabama, United States; Not yet recruiting

Research Site, Burnaby, British Columbia, Canada; Not yet recruiting

Research Site, Kelowna, British Columbia, Canada; Recruiting

Research Site, Vancouver, British Columbia, Canada; Recruiting

Research Site, Ramos Mejia, Buenos Aires, Argentina; Not yet recruiting

Research Site, Berkeley, California, United States; Recruiting

Research Site, Los Angeles, California, United States; Recruiting

Research Site, Santa Rosa, California, United States; Recruiting

Research Site, Santa Monica, California, United States; Not yet recruiting

Research Site, Boynton Beach, Florida, United States; Recruiting

Research Site, FORT MYERS, Florida, United States; Recruiting

Research Site, JACKSONVILLE, Florida, United States; Recruiting

Research Site, PORT ST LUCIE, Florida, United States; Recruiting

Research Site, PRAHRAN, Australia; Recruiting

Research Site, Songkla, Thailand; Recruiting

Research Site, Lampang, Thailand; Recruiting

Research Site, CAMBRIDGE, United Kingdom; Recruiting

Research Site, LEICESTER, United Kingdom; Recruiting

Research Site, HORNSBY, Australia; Recruiting

Research Site, NIEUWEGEIN, Netherlands; Recruiting

Research Site, HARDERWIJK, Netherlands; Recruiting

Research Site, ROTTERDAM, Netherlands; Recruiting

Research Site, Saltillo, Mexico; Recruiting

Research Site, Guadalajara, Mexico; Not yet recruiting

Research Site, Xalapa, Mexico; Not yet recruiting

Research Site, Juchitan, Mexico; Recruiting

Research Site, Zacatecas, Mexico; Recruiting

Research Site, Buenos Aires, Argentina; Recruiting

Research Site, Heidelberg, Germany; Recruiting

Research Site, Mainz, Germany; Recruiting

Research Site, Ulm, Germany; Recruiting

Research Site, Essen, Germany; Not yet recruiting

Research Site, WOLVERHAMPTON, United Kingdom; Recruiting

Research Site, NAPOLI, Italy; Not yet recruiting

Research Site, MANTOVA, Italy; Recruiting

Research Site, PARMA, Italy; Not yet recruiting

Research Site, REGGIO EMILIA, Italy; Not yet recruiting

Research Site, ROMA, Italy; Not yet recruiting

Research Site, Naestved, Denmark; Recruiting

Research Site, Arhus C, Denmark; Terminated

Research Site, CAEN, France; Recruiting

Research Site, Santa Fe, Argentina; Recruiting

Research Site, Sao Paulo, Brazil; Recruiting

Research Site, Geelong, Australia; Recruiting

Research Site, Ciudad de Bureno, Argentina; Recruiting

Research Site, GOIÂNIA, Brazil; Recruiting

Research Site, Rosario, Argentina; Recruiting

Research Site, Belo Horizonte, Brazil; Not yet recruiting

Research Site, Pamplona, Spain; Recruiting

Research Site, TAICHUNG, Taiwan; Recruiting

Research Site, TAIPEI, Taiwan; Recruiting

Research Site, TAO-YUAN, Taiwan; Recruiting

Research Site, Perugia, Italy; Recruiting

Research Site, Seoul, Korea, Republic of; Recruiting

Research Site, ORBASSANO, Italy; Recruiting

Research Site, GENOVA, Italy; Recruiting

Research Site, ROZZANO, Italy; Recruiting

Research Site, MILANO, Italy; Recruiting

Research Site, TAINAN, Taiwan; Recruiting

Research Site, Tao-Yuan, Taiwan; Recruiting

Research Site, Bangkok, Thailand; Recruiting

Research Site, Chiang Mai, Thailand; Recruiting

Research Site, HAUGESUND, Norway; Recruiting

Research Site, KRISTIANSAND, Norway; Recruiting

Research Site, LORENSKOG, Norway; Not yet recruiting

Research Site, OSLO, Norway; Recruiting

Research Site, STAVANGER, Norway; Recruiting

Research Site, Puebla, Mexico; Not yet recruiting

Research Site, Monterrey, Mexico; Not yet recruiting

Research Site, AVELLINO, Italy; Recruiting

Research Site, La Torretta, Italy; Recruiting

Research Site, BOLOGNA, Italy; Not yet recruiting

Research Site, CATANIA, Italy; Recruiting

Research Site, Porto Alegre, Brazil; Recruiting

Research Site, Curitiba, Brazil; Recruiting

Research Site, BERGEN, Norway; Recruiting

Research Site, CAMPINAS, Brazil; Not yet recruiting

Research Site, Wodonga, Australia; Recruiting

Research Site, Karlsruhe, Germany; Recruiting

Research Site, New Delhi, India; Recruiting

Research Site, Monchengladbach, Germany; Recruiting

Research Site, Lowenstein, Germany; Recruiting

Research Site, BIRMINGHAM, United Kingdom; Recruiting

Research Site, LIVERPOOL, United Kingdom; Recruiting

Research Site, NOTTINGHAM, United Kingdom; Recruiting

Research Site, SHEFFIELD, United Kingdom; Recruiting

Research Site, Caxias Do Sul, Brazil; Not yet recruiting

Research Site, BRASÍLIA, Brazil; Not yet recruiting

Research Site, Gonnet, Argentina; Recruiting

Research Site, Malvern, Australia; Recruiting

Research Site, Trivandrum, India; Recruiting

Research Site, BANDUNG, Indonesia; Recruiting

Research Site, SOLO, Indonesia; Recruiting

Research Site, JAKARTA, Indonesia; Recruiting

Research Site, Nanning, China; Recruiting

Research Site, Herlev, Denmark; Recruiting

Research Site, Kobenhavn, Denmark; Recruiting

Research Site, Kogarah, Australia; Recruiting

Research Site, Ashford, Australia; Recruiting

Research Site, Cordoba, Argentina; Recruiting

Research Site, Bedford Park, Australia; Recruiting

Research SIte, Porto Alegre, Brazil; Recruiting

Research Site, Santo André, Brazil; Recruiting

Research Site, Chermside, Australia; Recruiting

Research Site, Malaga, Spain; Recruiting

Research Site, Mataro, Spain; Recruiting

Research Site, Madrid, Spain; Recruiting

Research Site, Elche, Spain; Recruiting

Research Site, Hangzhou, China; Recruiting

Research Site, Shanghai, China; Recruiting

Research Site, Beijing, China; Recruiting

Research Site, Göttingen, Germany; Recruiting

Research Site, Hannover, Germany; Recruiting

Research Site, Großhansdorf, Germany; Recruiting

Research Site, TROMSO, Norway; Recruiting

Research Site, TRONDHEIM, Norway; Not yet recruiting

Research Site, Pasig City, Philippines; Recruiting

Research Site, Cebu City, Philippines; Recruiting

Research Site, Hong Kong, Hong Kong; Recruiting

Research Site, Karnataka, India; Recruiting

Research Site, Pune, India; Recruiting

Research Site, Bangalore, India; Recruiting

Research Site, MARSEILLE, France; Recruiting

Research Site, PARIS, France; Recruiting

Research Site, Montpellier Cedex, France; Not yet recruiting

Research Site, VESOUL CEDEX, France; Recruiting

Research Site, CLERMONT FERRAND, France; Recruiting

Research Site, RENNES, France; Recruiting

Research Site, ZWOLLE, Netherlands; Recruiting

Research Site, Dalian, China; Not yet recruiting

Research Site, Shenyang, China; Recruiting

Research Site, Nanjing, China; Recruiting

Research Site, Davao City, Philippines; Not yet recruiting

Research Site, Manila, Philippines; Recruiting

Research Site, Quezon City, Philippines; Recruiting

Research Site, Jaen, Spain; Recruiting

Research Site, Wuhan, Hubei, China; Recruiting

Research Site, Muncie, Indiana, United States; Not yet recruiting

Research Site, Wichita, Kansas, United States; Recruiting

Research Site, Lexington, Kentucky, United States; Not yet recruiting

Research Site, LOUISVILLE, Kentucky, United States; Not yet recruiting

Research Site, Paducah, Kentucky, United States; Terminated

Research Site, Metairie, Louisiana, United States; Recruiting

Research Site, WINNIPEG, Manitoba, Canada; Not yet recruiting

Research Site, Baltimore, Maryland, United States; Not yet recruiting

Research Site, Rockville, Maryland, United States; Not yet recruiting

Research Site, Kalamazoo, Michigan, United States; Not yet recruiting

Research Site, Morelia, Michoacan, Mexico; Not yet recruiting

Research Site, COLUMBIA, Missouri, United States; Recruiting

Research Site, ST. LOUIS, Missouri, United States; Recruiting

Research Site, LATHAM, New York, United States; Recruiting

Research Site, HICKORY, North Carolina, United States; Recruiting

Research Site, Canton, Ohio, United States; Not yet recruiting

Research Site, CINCINNATI, Ohio, United States; Recruiting

Research Site, Mississauga, Ontario, Canada; Recruiting

Research Site, Ottawa, Ontario, Canada; Recruiting

Research Site, Oshawa, Ontario, Canada; Recruiting

Research Site, Sault Ste Marie, Ontario, Canada; Recruiting

Research Site, Toronto, Ontario, Canada; Recruiting

Research Site, York, Ontario, Canada; Recruiting

Research Site, THUNDER BAY, Ontario, Canada; Not yet recruiting

Research Site, Kingston, Ontario, Canada; Terminated

Research Site, Charlottetown, Prince Edward Island, Canada; Recruiting

Research Site, Montreal, Quebec, Canada; Recruiting

Research Site, Laval, Quebec, Canada; Recruiting

Research Site, LEVIS, Quebec, Canada; Terminated

Research Site, GREENVILLE, South Carolina, United States; Recruiting

Research Site, Nashville, Tennessee, United States; Recruiting

Research Site, CHATTANOOGA, Tennessee, United States; Recruiting

Research Site, AMARILLO, Texas, United States; Recruiting

Research Site, GARLAND, Texas, United States; Recruiting

Research Site, LEWISVILLE, Texas, United States; Not yet recruiting

Research Site, WEBSTER, Texas, United States; Recruiting

Research Site, PARKVILLE, Victoria, Australia; Terminated

Research Site, FAIRFAX, Virginia, United States; Recruiting

Research Site, NORFOLK, Virginia, United States; Recruiting

Research Site, Richmond, Virginia, United States; Not yet recruiting

Research Site, BURIEN, Washington, United States; Recruiting

Research Site, YAKIMA, Washington, United States; Recruiting

Starting date: August 2006
Last updated: September 26, 2007