Clinical trial · Observational
Iressa Case Control Study in Japan
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKawata 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. PMID 30762084