Carcinoma, Non-Small-Cell LungPhase 2NCT00059722
This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.
A Phase 2 study testing ZD6474 and ZD1839 in people with Carcinoma, Non-Small-Cell Lung, run by Genzyme, a Sanofi Company at 48 sites in 6 countries.
Trial summary
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- ZD6474 and ZD1839
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 48 sitesin 6 countries
- Study dates
- May 2003to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
- Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC
Who cannot join
- Subjects who have received second-line or subsequent chemotherapy
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)
Trial locations and contacts
48 sites in 6 countries.
48 sites in 6 countries
United States18 sites
Research Site
Bismarck, North Dakota
Research Site
Boca Raton, Florida
Research Site
Brooklyn, New York
Research Site
Chicago, Illinois
Research Site
Coeur d'Alene, Idaho
Research Site
Greenville, North Carolina
Research Site
Indianapolis, Indiana
Research Site
Jacksonville, Florida
Research Site
Los Angeles, California
Research Site
Madison, Wisconsin
Research Site
New York, New York
Research Site
Orange Park, Florida
Research Site
Palm Springs, California
Research Site
Pine Bluff, Arkansas
Research Site
Saint Loius, Missouri
Research Site
San Diego, California
Research Site
Shreveport, Louisiana
Research Site
St Louis, Missouri
Germany9 sites
Research Site
Berlin, State of Berlin
Research Site
Berlin
Research Site
Essen, North Rhine-Westphalia
Research Site
Essen
Research Site
Hamburg, Free and Hanseatic City of Hamburg
Research Site
Hamburg
Research Site
Mainz, Rhineland-Palatinate
Research Site
Mainz
Research Site
Ryhope, Sunderland
South Africa8 sites
Research Site
Bloemfontein
Research Site
Cape Town
Research Site
Durban
Research Site
Johannesburg
Research Site
Lyttelton Manor
Research Site
Parktown
Research Site
Port Elizabeth
Research Site
Pretoria
Belgium6 sites
Research Site
Brussels
Research Site
Brussels (Jette)
Research Site
Brussels (Woluwé-St-Lambert)
Research Site
Edegem
Research Site
Liège
Research Site
Wilrijk
United Kingdom5 sites
Research Site
Cardiff, South Glamorgan
Research Site
Edinburgh
Research Site
Leeds
Research Site
Manchester
Research Site
Northwood, Middlesex
About this study
Official title: A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- ZD6474, Placebo, ZD1839
- Keywords
- NSCLC, locally advanced or metastatic, second-line
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD6474Drug
PlaceboDrug
ZD1839Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcomes:
Part A
i. Time to progression
ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes
Part B
Secondary outcomes (12)
Secondary Outcomes:
Part A
i. Objective response
ii. Disease control at 8 weeks
iii. Time to death
iv. WHO performance status
v. QOL and LCS from the FACT-L questionnaire
Part B
i. Objective response in subjects following treatment with the alternate study treatment
ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
iii. WHO performance status in subjects following treatment with the alternate study treatment
iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2003 (estimated)
- Study startMay 2003
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059722
- Sponsor's protocol ID
- 6474IL/0003
- Status last verified
- Aug 2016
- First submitted
- 2 May 2003
- Last updated
- 24 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.
- ClinicalTrials.gov ID
- NCT00059722
- Acronym / sponsor ID
- 6474IL/0003
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC, locally advanced or metastatic, second-line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Jun 2007 (actual)
- First posted
- 5 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
- Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC
Key exclusion criteria (2 listed)
- Subjects who have received second-line or subsequent chemotherapy
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD6474 | Drug | – |
| Placebo | Drug | – |
| ZD1839 | Drug | – |
Primary outcome
Primary Outcomes:
Part A
i. Time to progression
ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes
Part B
12 secondary outcomes
Secondary Outcomes:
Part A
i. Objective response
ii. Disease control at 8 weeks
iii. Time to death
iv. WHO performance status
v. QOL and LCS from the FACT-L questionnaire
Part B
i. Objective response in subjects following treatment with the alternate study treatment
ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
iii. WHO performance status in subjects following treatment with the alternate study treatment
iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
48 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD6474 and ZD1839 in people with Carcinoma, Non-Small-Cell Lung, run by Genzyme, a Sanofi Company at 48 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Germany, South Africa, Belgium, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcomes:. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.