Clinical trial · Observational
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
An Observational, Non-interventional, Multi-center, Chart Review Study Conducted Among Patients Enrolled in an AZD9291 Early Access Program in Hong Kong, With Locally Advanced/Metastatic EGFR T790M Mutation-positive NSCLC and Prior Exposure to EGFR TKI Therapy.
NCT03219970CI-TRIAL-00053882completedClinicalTrials.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)
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- EGFR T790M positive NSCLC patients
- description
- Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment.
- interventionNames
- Drug: Osimertinib
Primary outcomes (1)
- measure
- Association between T790M mutant status and overal survival
- timeFrame
- Followed up to 2 years after last patient in
- description
- To assess the association of EGFR T790M mutant allele fraction (AF) level with the overall survival (OS) of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
Secondary outcomes (8)
- measure
- Overal survival (OS)
- timeFrame
- Followed up to 2 years after last patient in
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients enrolled in AZD9291 Named Patient Program in Hong Kong * Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation * Patients who have previously received EGFR TKI therapy or discontinued an EGFR TKI at the time of enrolment in the study * Provision of written informed consent (for patients alive at the time of study enrolment) * Documented patients with trackable medical records Exclusion Criteria: * Enrolment in studies that prohibit any participation in this non-interventional study
References
Publications (0)
Data not yet available
No reference posted for this study.