Clinical trial NCT00364351: Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
NSCLC
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 1574
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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:
measure: Overall Survival (OS)
timeFrame: Time to death in months
measure: Objective Response Rate (ORR)
timeFrame: 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
measure: Disease Control Rate (DCR)
timeFrame: RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression
measure: Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain
timeFrame: 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
measure: Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea
timeFrame: 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
measure: Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough
timeFrame: 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
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Fort Myers
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Port Saint Lucie
country: United States
facility: Research Site
state: Florida
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
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state: Kentucky
city: Louisville
country: United States
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state: Kentucky
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
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state: Maryland
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Latham
country: United States
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state: New York
city: Hickory
country: United States
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state: North Carolina
city: Canton
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Greenville
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state: South Carolina
city: Chattanooga
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state: Tennessee
city: Nashville
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state: Tennessee
city: Amarillo
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state: Texas
city: Garland
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city: Webster
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state: Virginia
city: Norfolk
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city: Richmond
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state: Washington
city: Yakima
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state: Washington
city: Ciudad de Buenos Aires
country: Argentina
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country: Argentina
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country: Argentina
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country: Australia
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country: Australia
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city: Malvern
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city: Wodonga
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city: Belo Horizonte
country: Brazil
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city: Caxias do Sul
country: Brazil
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city: Curitiba
country: Brazil
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city: Goiânia
country: Brazil
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city: Kelowna
country: Canada
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state: British Columbia
city: Vancouver
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city: Winnipeg
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state: Manitoba
city: Oshawa
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city: Ottawa
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city: Sault Ste. Marie
country: Canada
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city: Thunder Bay
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city: York
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city: Montreal
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state: Quebec
city: Beijing
country: China
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city: Dalian
country: China
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city: Hangzhou
country: China
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city: Nanjing
country: China
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city: Nanning
country: China
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city: Shanghai
country: China
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city: Shenyang
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city: Wuhan
country: China
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city: Herlev
country: Denmark
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city: København Ø
country: Denmark
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city: Næstved
country: Denmark
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city: Caen
country: France
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city: Clermont Ferrand
country: France
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city: Marseille
country: France
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city: Paris Cedex 12
country: France
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city: RENNES Cedex 9
country: France
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city: Vesoul Cedex
country: France
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city: Großhansdorf
country: Germany
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city: Göttingen
country: Germany
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city: Hannover
country: Germany
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city: Heidelberg
country: Germany
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city: Karlsruhe
country: Germany
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city: Löwenstein
country: Germany
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city: Mainz
country: Germany
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city: Mönchengladbach
country: Germany
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city: Ulm
country: Germany
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city: Hong Kong
country: Hong Kong
facility: Research Site
city: Bangalore
country: India
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city: Karnataka
country: India
facility: Research Site
city: New Delhi
country: India
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city: Pune
country: India
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city: Trivandrum
country: India
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city: Bandung
country: Indonesia
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city: Jakarta
country: Indonesia
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city: Solo
country: Indonesia
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city: Ancona
country: Italy
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city: Avellino
country: Italy
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city: Catania
country: Italy
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city: Genova
country: Italy
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city: Mantova
country: Italy
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city: Milano
country: Italy
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city: Orbassano
country: Italy
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city: Parma
country: Italy
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city: Perugia
country: Italy
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city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Juchitan
country: Mexico
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city: Monterrey
country: Mexico
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city: Morelia
country: Mexico
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city: Puebla
country: Mexico
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city: Saltillo
country: Mexico
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city: Zacatecas
country: Mexico
facility: Research Site
city: Harderwijk
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Zwolle
country: Netherlands
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city: Bergen
country: Norway
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city: Haugesund
country: Norway
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city: Kristiansand
country: Norway
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city: Oslo
country: Norway
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city: Stavanger
country: Norway
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city: Tromsø
country: Norway
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city: Trondheim
country: Norway
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
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city: Pasay City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Elche(Alicante)
country: Spain
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city: Jaén
country: Spain
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city: Madrid
country: Spain
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city: Mataró(Barcelona)
country: Spain
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city: Málaga
country: Spain
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city: Pamplona
country: Spain
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
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city: Chiang Mai
country: Thailand
facility: Research Site
city: Lampang
country: Thailand
facility: Research Site
city: Songkla
country: Thailand
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.