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

Phase 4

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-jRCT1080220403
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Observational
• Study Design: Not specified