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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vandetanib
Erlotinib
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Erlotinib

Vandetanib

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
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).
Objective Response Rate (ORR)
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.
Disease Control Rate (DCR)
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.
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain
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.
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea
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.
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough
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.

Full Information

First Posted
August 14, 2006
Last Updated
January 24, 2018
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00364351
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Non Small Cell Lung Cancer, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1574 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Erlotinib
Arm Title
2
Arm Type
Experimental
Arm Description
Vandetanib
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Other Intervention Name(s)
ZD6474, ZACTIMA™
Intervention Description
once daily oral tablet
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva®
Intervention Description
oral dose
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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).
Time Frame
Time to death in months
Title
Objective Response Rate (ORR)
Description
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.
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
Title
Disease Control Rate (DCR)
Description
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.
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
Title
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain
Description
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.
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
Title
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea
Description
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.
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
Title
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Berkeley
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Santa Rosa
State/Province
California
Country
United States
Facility Name
Research Site
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Port Saint Lucie
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Latham
State/Province
New York
Country
United States
Facility Name
Research Site
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
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City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
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Research Site
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Garland
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Webster
State/Province
Texas
Country
United States
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City
Fairfax
State/Province
Virginia
Country
United States
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Research Site
City
Norfolk
State/Province
Virginia
Country
United States
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Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Burien
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Yakima
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Córdoba
Country
Argentina
Facility Name
Research Site
City
Gonnet
Country
Argentina
Facility Name
Research Site
City
Ramos Mejía
Country
Argentina
Facility Name
Research Site
City
Rosario
Country
Argentina
Facility Name
Research Site
City
Santa Fe
Country
Argentina
Facility Name
Research Site
City
Ashford
Country
Australia
Facility Name
Research Site
City
Bedford Park
Country
Australia
Facility Name
Research Site
City
Chermside
Country
Australia
Facility Name
Research Site
City
Geelong
Country
Australia
Facility Name
Research Site
City
Hornsby
Country
Australia
Facility Name
Research Site
City
Kogarah
Country
Australia
Facility Name
Research Site
City
Malvern
Country
Australia
Facility Name
Research Site
City
Prahran
Country
Australia
Facility Name
Research Site
City
Wodonga
Country
Australia
Facility Name
Research Site
City
Belo Horizonte
Country
Brazil
Facility Name
Research Site
City
Caxias do Sul
Country
Brazil
Facility Name
Research Site
City
Curitiba
Country
Brazil
Facility Name
Research Site
City
Goiânia
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
Country
Brazil
Facility Name
Research Site
City
Santo André
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
Country
Brazil
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Sault Ste. Marie
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
York
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Charlottetown
State/Province
Prince Edward Island
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Beijing
Country
China
Facility Name
Research Site
City
Dalian
Country
China
Facility Name
Research Site
City
Hangzhou
Country
China
Facility Name
Research Site
City
Nanjing
Country
China
Facility Name
Research Site
City
Nanning
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
Facility Name
Research Site
City
Shenyang
Country
China
Facility Name
Research Site
City
Wuhan
Country
China
Facility Name
Research Site
City
Herlev
Country
Denmark
Facility Name
Research Site
City
København Ø
Country
Denmark
Facility Name
Research Site
City
Næstved
Country
Denmark
Facility Name
Research Site
City
Caen
Country
France
Facility Name
Research Site
City
Clermont Ferrand
Country
France
Facility Name
Research Site
City
Marseille
Country
France
Facility Name
Research Site
City
Paris Cedex 12
Country
France
Facility Name
Research Site
City
RENNES Cedex 9
Country
France
Facility Name
Research Site
City
Vesoul Cedex
Country
France
Facility Name
Research Site
City
Großhansdorf
Country
Germany
Facility Name
Research Site
City
Göttingen
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Heidelberg
Country
Germany
Facility Name
Research Site
City
Karlsruhe
Country
Germany
Facility Name
Research Site
City
Löwenstein
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
Mönchengladbach
Country
Germany
Facility Name
Research Site
City
Ulm
Country
Germany
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Karnataka
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Pune
Country
India
Facility Name
Research Site
City
Trivandrum
Country
India
Facility Name
Research Site
City
Bandung
Country
Indonesia
Facility Name
Research Site
City
Jakarta
Country
Indonesia
Facility Name
Research Site
City
Solo
Country
Indonesia
Facility Name
Research Site
City
Ancona
Country
Italy
Facility Name
Research Site
City
Avellino
Country
Italy
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Mantova
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Orbassano
Country
Italy
Facility Name
Research Site
City
Parma
Country
Italy
Facility Name
Research Site
City
Perugia
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Juchitan
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
Morelia
Country
Mexico
Facility Name
Research Site
City
Puebla
Country
Mexico
Facility Name
Research Site
City
Saltillo
Country
Mexico
Facility Name
Research Site
City
Zacatecas
Country
Mexico
Facility Name
Research Site
City
Harderwijk
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Zwolle
Country
Netherlands
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Haugesund
Country
Norway
Facility Name
Research Site
City
Kristiansand
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Stavanger
Country
Norway
Facility Name
Research Site
City
Tromsø
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Cebu City
Country
Philippines
Facility Name
Research Site
City
Davao City
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Pasay City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Elche(Alicante)
Country
Spain
Facility Name
Research Site
City
Jaén
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Mataró(Barcelona)
Country
Spain
Facility Name
Research Site
City
Málaga
Country
Spain
Facility Name
Research Site
City
Pamplona
Country
Spain
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Tainan
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Tao-Yuan
Country
Taiwan
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
Facility Name
Research Site
City
Lampang
Country
Thailand
Facility Name
Research Site
City
Songkla
Country
Thailand
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
Country
United Kingdom
Facility Name
Research Site
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21282542
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.
Results Reference
result
PubMed Identifier
25881079
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=347&filename=Vandetanib_study_57_ZEST_CSP_redacted_SECURE.pdf
Description
Vandetanib_study_57_ZEST_CSP_redacted_SECURE

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

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