Non-Small Cell Lung CancerPhase 3NCT00252707
Iressa 2nd Line Phase III Study in Japan
A Phase 3 study testing Gefitinib or Docetaxel in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 40 sites in Japan.
Trial summary
In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Gefitinib or Docetaxel
- How many people
- 484 participants
- Where
- 40 sitesJapan
- Study dates
- Sep 2003to Nov 2006
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
- You have been treated with chemotherapy including platinums for NSCLC.
Who cannot join
- You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
- You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
- You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Japan40 sites
Research Site
Akashi, Hyōgo
Research Site
Asahikawa, Hokkaido
Research Site
Beppu, Oita Prefecture
Research Site
Bunkyo-ku, Tokyo
Research Site
Chūō, Tokyo
Research Site
Fukuoka, Fukuoka
Research Site
Gifu, Gifu
Research Site
Habikino, Osaka
Research Site
Hirosaki, Aomori
Research Site
Isehara, Kanagawa
Research Site
Iwata, Shizuoka
Research Site
Izumisano, Osaka
Research Site
Kanazawa
Research Site
Kashiwa, Chiba
Research Site
Kiyose, Tokyo
Research Site
Kobe, Hyōgo
Research Site
Kumamoto, Kumamoto
Research Site
Matsuyama, Ehime
Research Site
Minato-ku, Tokyo
Research Site
Nagasaki, Nagasaki
Research Site
Nagoya, Aichi-ken
Research Site
Naka-gun, Ibaraki
Research Site
Niigata, Niigata
Research Site
Okayama, Okayama-ken
Research Site
Okazaki, Aichi-ken
Research Site
Ōmura, Nagasaki
Research Site
Osaka, Osaka
Research Site
Sagamihara, Kanagawa
Research Site
Sakai, Osaka
Research Site
Sapporo, Hokkaido
Research Site
Sayama, Osaka
Research Site
Sendai, Miyagi
Research Site
Shinjuku, Tokyo
Research Site
Sumida City, Tokyo
Research Site
Sunto-gun, Shizuoka
Research Site
Toshima-ku, Tokyo
Research Site
Toyonaka, Osaka
Research Site
Ube, Yamaguchi
Research Site
Yamagata, Yamagata
Research Site
Yokohama, Kanagawa
About this study
Official title: A Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens
In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Gefitinib or Docetaxel
- 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.
Gefitinib or DocetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the overall survival with these treatments as the primary outcome.
Secondary outcomes (10)
Determine the followings as the secondary outcome variables:
- Progression-free survival (PFS)
- Time to treatment failure (TTF)
- Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
- Lung cancer subscale (LCS)
- QOL according to FACT-L questionnaire
- Frequency and severity of adverse events.
Determine the followings as the exploratory outcome variables:
- Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
- Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startSep 2003
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies 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
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Japan Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252707
- Sponsor's protocol ID
- D791AL00001
- Other IDs
- V-15-32
- Status last verified
- Dec 2007
- First submitted
- 14 Nov 2005
- Last updated
- 18 Dec 2007
- Results posted
- No
Publications
Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008 Sep 10;26(26):4244-52. doi: 10.1200/JCO.2007.15.0185.
PubMed 18779611
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT00252707
- Acronym / sponsor ID
- D791AL00001
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Nov 2006 (actual)
- First posted
- 15 Nov 2005 (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.
In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
- You have been treated with chemotherapy including platinums for NSCLC.
Key exclusion criteria (3 listed)
- You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
- You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
- You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
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 or Docetaxel | Drug | – |
Primary outcome
Determine the overall survival with these treatments as the primary outcome.
10 secondary outcomes
Determine the followings as the secondary outcome variables:
- Progression-free survival (PFS)
- Time to treatment failure (TTF)
- Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
- Lung cancer subscale (LCS)
- QOL according to FACT-L questionnaire
- Frequency and severity of adverse events.
Determine the followings as the exploratory outcome variables:
- Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
- Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells.
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 18 Dec 2007.
- Derived from this study: PubMed 18779611Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008 Sep 10;26(26):4244-52. doi: 10.1200/JCO.2007.15.0185.
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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 Japan Medical Director, MD study director
AstraZeneca
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gefitinib or Docetaxel in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 40 sites in Japan.
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 3 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 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Japan. 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?
Determine the overall survival with these treatments as the primary outcome.. 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 NCT00252707, which also lists 1 linked publication.
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 18 Dec 2007.