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

  • Argentina
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Gonnet, Argentina
        • Research Site
      • Ramos Mejía, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
  • Australia
      • Ashford, Australia
        • Research Site
      • Bedford Park, Australia
        • Research Site
      • Chermside, Australia
        • Research Site
      • Geelong, Australia
        • Research Site
      • Hornsby, Australia
        • Research Site
      • Kogarah, Australia
        • Research Site
      • Malvern, Australia
        • Research Site
      • Prahran, Australia
        • Research Site
      • Wodonga, Australia
        • Research Site
  • Brazil
      • Belo Horizonte, Brazil
        • Research Site
      • Caxias do Sul, Brazil
        • Research Site
      • Curitiba, Brazil
        • Research Site
      • Goiânia, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
      • Santo André, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Research Site
      • Vancouver, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Ontario
      • Oshawa, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Sault Ste. Marie, Ontario, Canada
        • Research Site
      • Thunder Bay, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • York, Ontario, Canada
        • Research Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • Research Site
    • Quebec
      • Laval, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
  • China
      • Beijing, China
        • Research Site
      • Dalian, China
        • Research Site
      • Hangzhou, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Nanning, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Shenyang, China
        • Research Site
      • Wuhan, China
        • Research Site
  • Denmark
      • Herlev, Denmark
        • Research Site
      • København Ø, Denmark
        • Research Site
      • Næstved, Denmark
        • Research Site
  • France
      • Caen, France
        • Research Site
      • Clermont Ferrand, France
        • Research Site
      • Marseille, France
        • Research Site
      • Paris Cedex 12, France
        • Research Site
      • RENNES Cedex 9, France
        • Research Site
      • Vesoul Cedex, France
        • Research Site
  • Germany
      • Großhansdorf, Germany
        • Research Site
      • Göttingen, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Karlsruhe, Germany
        • Research Site
      • Löwenstein, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Mönchengladbach, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Karnataka, India
        • Research Site
      • New Delhi, India
        • Research Site
      • Pune, India
        • Research Site
      • Trivandrum, India
        • Research Site
  • Indonesia
      • Bandung, Indonesia
        • Research Site
      • Jakarta, Indonesia
        • Research Site
      • Solo, Indonesia
        • Research Site
  • Italy
      • Ancona, Italy
        • Research Site
      • Avellino, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Mantova, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Orbassano, Italy
        • Research Site
      • Parma, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Rozzano, Italy
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
  • Mexico
      • Juchitan, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
      • Morelia, Mexico
        • Research Site
      • Puebla, Mexico
        • Research Site
      • Saltillo, Mexico
        • Research Site
      • Zacatecas, Mexico
        • Research Site
  • Netherlands
      • Harderwijk, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Zwolle, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Haugesund, Norway
        • Research Site
      • Kristiansand, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Tromsø, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Davao City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Pasay City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Spain
      • Elche(Alicante), Spain
        • Research Site
      • Jaén, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Mataró(Barcelona), Spain
        • Research Site
      • Málaga, Spain
        • Research Site
      • Pamplona, Spain
        • Research Site
  • Taiwan
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-Yuan, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
      • Lampang, Thailand
        • Research Site
      • Songkla, Thailand
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Cambridge, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Wolverhampton, United Kingdom
        • Research Site
  • United States
    • California
      • Berkeley, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Santa Rosa, California, United States
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States
        • Research Site
      • Fort Myers, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Port Saint Lucie, Florida, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Research Site
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
      • Saint Louis, Missouri, United States
        • Research Site
    • New York
      • Latham, New York, United States
        • Research Site
    • North Carolina
      • Hickory, North Carolina, United States
        • Research Site
    • Ohio
      • Canton, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Amarillo, Texas, United States
        • Research Site
      • Garland, Texas, United States
        • Research Site
      • Webster, Texas, United States
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States
        • Research Site
      • Norfolk, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Burien, Washington, United States
        • Research Site
      • Yakima, Washington, United States
        • Research Site

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
Experimental: 2
Vandetanib
Drug: Vandetanib
once daily oral tablet
Other Names:
  • ZD6474
  • ZACTIMA™
Active Comparator: 1
Erlotinib
Drug: Erlotinib
oral dose
Other Names:
  • Tarceva®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Time to death in months
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 to death in months
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
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.
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)
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
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.
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
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

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
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

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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

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

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

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.

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