Non-Small-Cell Lung CarcinomaPhase 3NCT00076388
Iressa Versus Docetaxel (Taxotere)
A Phase 3 study testing Gefitinib and Docetaxel in people with Non-Small-Cell Lung Carcinoma, run by AstraZeneca at 162 sites in 25 countries.
Trial summary
The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- Gefitinib and Docetaxel
- How many people
- 1,440 participants
- Where
- 162 sitesin 25 countries
- Study dates
- Feb 2004to Oct 2007
- Phase
- Phase 3
- 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
- Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
- WHO performance status (PS) 0-2
- Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L
- Life expectancy of at least 8 weeks
Who cannot join
- Prior ZD1839 therapy
- Prior docetaxel treatment for NSCLC
- Less than 14 days since completion of prior radiotherapy
- Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
- Evidence of clinically active Interstitial Lung Disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
- Patients with pre existing peripheral neuropathy >= grade 2 (NCI CTC criteria)
Trial locations and contacts
162 sites in 25 countries.
162 sites in 25 countries
United States35 sites
Research Site
Austin, Texas
Research Site
Birmingham, Alabama
Research Site
Boca Raton, Florida
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Charlotte, North Carolina
Research Site
Cleveland, Ohio, 44195
Research Site
Colorado Springs, Colorado
Research Site
Columbia, South Carolina
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Dallas, Texas
Research Site
Durham, North Carolina, 27710
Research Site
Fairfax, Virginia
Research Site
Fountain Valley, California
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Great Neck, New York, 11021
Research Site
Houston, Texas, 77030-4009
Research Site
Knoxville, Kentucky
Research Site
Los Angeles, California, 90048
Research Site
Macon, Georgia
Research Site
Nashville, Tennessee
Research Site
Newark, Delaware
Research Site
Norwich, Connecticut
Research Site
Orlando, Florida, 32806
Research Site
Philadelphia, Pennsylvania
Research Site
Pittsburgh, Pennsylvania
Research Site
Portland, Oregon
Research Site
Racine, Wisconsin
Research Site
Rochester, New York, 14621
Research Site
Saint Louis Park, Minnesota
Research Site
Salt Lake City, Utah
Research Site
Santa Rosa, California
Research Site
Seattle, Washington
Research Site
Skokie, Illinois, 60077
Research Site
Stockton, California, 95204
Research Site
Syracuse, New York, 13210
Research Site
Tucker, Georgia
Research Site
Tyler, Texas
Germany17 sites
Research Site
Bad Segeberg, Schleswig-Holstein
Research Site
Berlin
Research Site
Bonn
Research Site
Cologne
Research Site
Cottbus, Brandenburg
Research Site
Düsseldorf, North Rhine-Westphalia
Research Site
Frankfurt am Main, Hesse
Research Site
Großhansdorf
Research Site
Heidelberg, Baden-Wurttemberg
Research Site
Leverkusen
Research Site
Löwenstein
Research Site
Mainz, Rhineland-Palatinate
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Mannheim
Research Site
München
Research Site
Stuttgart
Research Site
Ulm, Baden-Wurttemberg
Research Site
Wiesbaden
Canada14 sites
Research Site
Edmonton, Alberta
Research Site
Greater Sudbury, Ontario
Research Site
Halifax, Nova Scotia
Research Site
Hamilton, Ontario
Research Site
Laval, Quebec
Research Site
London, Ontario
Research Site
Moncton, New Brunswick
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Montreal, Quebec
Research Site
Newmarket, Ontario
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Saint Catherines, Ontario
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Ste-Foy, Quebec
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Surrey, British Columbia
Research Site
Toronto, Ontario
Research Site
York, Ontario
Italy14 sites
Research Site
Bari, BA
Research Site
Bergamo, BG
Research Site
Bologna, BO
Research Site
Catania, CT
Research Site
Cuneo, CN
Research Site
Forlì, FO
Research Site
La Torretta, Ancona
Research Site
Melegnano, MI
Research Site
Modena, MO
Research Site
Naples
Research Site
Parma, PR
Research Site
Roma, Roma
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Rozzano, MI
Research Site
Torino, TO
France11 sites
Research Site
Blois
Research Site
Boulogne-Billancourt
Research Site
Caen
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Grenoble
Research Site
Le Mans
Research Site
Lille
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Nantes
Research Site
Niort
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Saint-Herblain
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Vandœuvre-lès-Nancy
Research Site
Vesoul
Spain9 sites
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Barcelona, Barcelona
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Elche, Alicante
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Girona, Gerona
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Madrid, Madrid
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Málaga, Málaga
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Seville, Sevilla
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Valencia, Valencia
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Vitoria-Gasteiz
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Zaragoza
Sweden9 sites
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Gothenburg
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Luleå
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Örebro
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Östersund
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Skövde
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Stockholm
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Sundsvall
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Umeå
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Västerås
Argentina8 sites
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Buenos Aires
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Córdoba
Research site
El Palomar
Research Site
Mar del Plata
Research Site
Quilmes
Research Site
Rosario
Research Site
San Miguel de Tucumán
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Santa Fe
Belgium8 sites
Research Site
Charleroi
Research Site
Edegem
Research Site
Genk
Research Site
Godinne
Research Site
Kortrijk
Research Site
Leuven
Research Site
Liège
Research Site
Yvoir
Denmark6 sites
Research Site
Aalborg
Research Site
Arhus C
Research Site
Glostrup Municipality
Research Site
Herlev
Research Site
København Ø
Research Site
Vejle
Mexico4 sites
Research Site
Guadalajara
Research Site
Monterrey
Research Site
Morelia
Research Site
Torreón
Brazil3 sites
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
São Paulo, São Paulo
Switzerland3 sites
Research Site
Bellinzona
Research Site
Sankt Gallen
Research Site
Zurich
Turkey (Türkiye)3 sites
Research Site
Ankara
Research Site
Istanbul
Research Site
Izmir
About this study
Official title: A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy
The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Non-Small-Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare overall survival between ZD1839 and docetaxel
Secondary outcomes (5)
To compare time to progression (TTP) between ZD1839 and docetaxel
To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
To compare the overall objective tumor response rate between ZD1839 and docetaxel
To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
To compare safety and tolerability of ZD1839 and docetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2004 (estimated)
- Study startFeb 2004
- Primary completionMar 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,440 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Iressa Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076388
- Sponsor's protocol ID
- D791GC00001
- Other IDs
- EudraCT No: 2004-002943-28, 1839IL/0721
- Status last verified
- May 2011
- First submitted
- 21 Jan 2004
- Last updated
- 13 May 2011
- Results posted
- No
Publications
Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.
PubMed 33075149Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. doi: 10.1200/JCO.2009.24.3030. Epub 2009 Dec 28.
PubMed 20038723Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18. doi: 10.1016/S0140-6736(08)61758-4.
PubMed 19027483
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00076388
- Acronym / sponsor ID
- D791GC00001
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Non-Small-Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Jan 2004 (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 effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
- WHO performance status (PS) 0-2
- Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L
Key exclusion criteria (8 listed)
- Prior ZD1839 therapy
- Prior docetaxel treatment for NSCLC
- Less than 14 days since completion of prior radiotherapy
- Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
- Evidence of clinically active Interstitial Lung Disease
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 |
|---|---|---|
| Gefitinib | Drug | – |
| Docetaxel | Drug | – |
Primary outcome
To compare overall survival between ZD1839 and docetaxel
5 secondary outcomes
To compare time to progression (TTP) between ZD1839 and docetaxel
To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
To compare the overall objective tumor response rate between ZD1839 and docetaxel
To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
To compare safety and tolerability of ZD1839 and docetaxel
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 13 May 2011.
- Derived from this study: PubMed 33075149Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.
- Derived from this study: PubMed 20038723Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. doi: 10.1200/JCO.2009.24.3030. Epub 2009 Dec 28.
- Derived from this study: PubMed 19027483Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18. doi: 10.1016/S0140-6736(08)61758-4.
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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.
AstraZeneca Iressa Medical Science Director, MD study director
AstraZeneca
162 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gefitinib and Docetaxel in people with Non-Small-Cell Lung Carcinoma, run by AstraZeneca at 162 sites in 25 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 6 inclusion and 8 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 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 162 sites in United States, Germany, Canada, Italy, France and 20 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To compare overall survival between ZD1839 and docetaxel. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00076388, which also lists 3 linked publications.
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 13 May 2011.