Clinical trial · Observational
Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)
NCT01103089CI-TRIAL-00005610completedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of the study is to determine patient characteristics from patients that have used Iressa for a period of minimal 3 years.
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
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC.
- timeFrame
- Characteristics will be recorded once, retrospectively
Secondary outcomes (3)
- measure
- To assess the long-term safety in subjects treated with gefitinib by collecting information on: All adverse events that have lead to an interruption/reduction of gefitinib or another intervention
- timeFrame
- Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
- measure
- long-term safety in subjects; what real life data measures are being taken by lung physicians to counter side effects caused by long term gefitinib treatment; the number, reason, effect and description of interventions that have been taken
- timeFrame
- Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Participation in the gefitinib Expanded Access Program * Patient still uses gefitinib in September 2009
References
Publications (0)
Data not yet available
No reference posted for this study.