Clinical trial · Observational
Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC
An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).
NCT03133234CI-TRIAL-00035887completedClinicalTrials.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 effectiveness and safety of osimertinib treatment 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 |
|---|---|---|---|
| T790M Positive NSCLC Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- EGFR T790M Patients
- description
- Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI
- interventionNames
- Drug: osimertinib
Primary outcomes (1)
- measure
- ORR
- timeFrame
- Followed up with 6 months after last patient in
- description
- Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment
Secondary outcomes (8)
- measure
- PFS
- timeFrame
- Followed up 10 months after last subject in
- description
- Progression free survival (PFS), defined as the time from the date of first dose of osimertinib to the date of investigator-assessed disease progression or death from any cause during study. Subjects who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Above 18 years of age; * Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy * Confirmed T790M mutation * Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment * Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016 Exclusion Criteria: • Enrolment in studies that prohibit any participation in this observational study
References
Publications (1)
- DERIVEDCao Y, Qiu X, Xiao G, Hu H, Lin T. Effectiveness and safety of osimertinib in patients with metastatic EGFR T790M-positive NSCLC: An observational real-world study. PLoS One. 2019 Aug 23;14(8):e0221575. doi: 10.1371/journal.pone.0221575. eCollection 2019. PMID 31442277