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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

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

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080220403
Enrollment
Unknown
Registered
2007-06-12
Start date
2007-06-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : Gefitinib INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materia

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Genders Eligible for Study: Both Criteria Inclusion Criteria: - 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 Exclusion Criteria: - 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

Exclusion criteria

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026