Iressa Case Control Study in Japan

An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 44 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purposes of this study are: To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment To provide an estimate of the incidence of ILD… Read more about this study

Who is it for?: Any age
Conditions the study is for: Non-small Cell Lung Cancer
How many people: 6,000 participants
Where: 44 sitesJapan
Study dates: Nov 2003to Feb 2006
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: patients

Who may be able to join

Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens.
Patients who are to be treated with gefitinib or chemotherapy
Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study

Who cannot join

Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case
Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

Japan44 sites

Research Site
Akashi, Hyōgo
Research Site
Asahikawa, Hokkaido
Research Site
Bunkyo, Tokyo
Research Site
Bunkyo-ku, Tokyo
Research Site
Fukuoka, Fukuoka
Research Site
Gifu, Gifu
Research Site
Ginowan, Okinawa
Research Site
Habikino, Osaka
Research Site
Hiroshima, Hiroshima
Research Site
Imba-gun, Chiba
Research Site
Isehara, Kanagawa
Research Site
Izumisano, Osaka
Research Site
Kanazawa, Ishikawa-ken
Research Site
Kashiwa, Chiba
Research Site
Kitakyushu, Fukuoka
Research Site
Kiyose, Tokyo
Research Site
Kobe, Hyōgo
Research Site
Kumamoto, Kumamoto
Research Site
Kyoto, Kyoto
Research Site
Matsuyama, Ehime
Research Site
Minato-ku, Tokyo
Research Site
Mitaka, Tokyo
Research Site
Nagasaki, Nagasaki
Research Site
Nagoya, Aichi-ken
Research Site
Niigata, Niigata
Research Site
Okayama, Okayama-ken
Research Site
Okazaki, Aichi-ken
Research Site
Ōmura, Nagasaki
Research Site
Osaka, Osaka
Research Site
Ōtsu, Shiga
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
Sunto-gun, Shizuoka
Research Site
Tenri, Nara
Research Site
Tokyo, Ota
Research Site
Toshima-ku, Tokyo
Research Site
Toyama, Toyama
Research Site
Toyoake, Aichi-ken
Research Site
Toyonaka, Osaka
Research Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib

The purposes of this study are:

To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment
To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment

Conditions: Non-small Cell Lung Cancer
Medical subject headings: Carcinoma, Non-Small-Cell Lung

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Feb 2006

First posted15 Nov 2005 (estimated)
Study startNov 2003
Study completionFeb 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: Observational
Time perspective: Prospective
Enrolment: 6,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00252759
Sponsor's protocol ID: D791AL00002
Other IDs: V-15-33, OZV1533
Status last verified: Jan 2011
First submitted: 14 Nov 2005
Last updated: 28 Jan 2011
Results posted: No

Publications

Kawata T, Higashimori M, Itoh Y, Tomkinson H, Johnson MG, Tang W, Nyberg F, Jiang H, Tanigawara Y. Gefitinib exposure and occurrence of interstitial lung disease in Japanese patients with non-small-cell lung cancer. Cancer Chemother Pharmacol. 2019 May;83(5):849-858. doi: 10.1007/s00280-019-03788-4. Epub 2019 Feb 14.
PubMed 30762084

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib
ClinicalTrials.gov ID: NCT00252759
Acronym / sponsor ID: D791AL00002
Conditions: Non-small Cell Lung Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 6,000 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2003
Study completion: Feb 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.

The purposes of this study are:

To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment
To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment

Study design

Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: patients

Key inclusion criteria (3 listed)

Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens.
Patients who are to be treated with gefitinib or chemotherapy
Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study

Key exclusion criteria (2 listed)

Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case
Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

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 28 Jan 2011.
Derived from this study: PubMed 30762084Kawata T, Higashimori M, Itoh Y, Tomkinson H, Johnson MG, Tang W, Nyberg F, Jiang H, Tanigawara Y. Gefitinib exposure and occurrence of interstitial lung disease in Japanese patients with non-small-cell lung cancer. Cancer Chemother Pharmacol. 2019 May;83(5):849-858. doi: 10.1007/s00280-019-03788-4. Epub 2019 Feb 14.

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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

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 44 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 3 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 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00252759, 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 28 Jan 2011; AzTrials last refreshed its copy on 30 Oct 2026.