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).
1 other identifier
observational
47
1 country
1
Brief Summary
To assess the effectiveness and safety of osimertinib treatment in a real world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedStudy Start
First participant enrolled
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2017
CompletedNovember 20, 2018
November 1, 2018
4 months
April 13, 2017
November 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment
Followed up with 6 months after last patient in
Secondary Outcomes (8)
PFS
Followed up 10 months after last subject in
T790M mutation testing time
Within 14 days after enrollment date
Treatment patterns
Followed up 10 months after last patient in
Adverse events
Follow up 10 months after last patient in.
Adverse event intensity
Follow up 10 months after last patient in.
- +3 more secondary outcomes
Study Arms (1)
EGFR T790M Patients
Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI
Interventions
Eligibility Criteria
Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed after EGFR TKI treatment.
You may qualify if:
- 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
You may not qualify if:
- Enrolment in studies that prohibit any participation in this observational study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Kiang Wu Hospital
Macau, China
Related Publications (1)
Cao 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: 31442277DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Yabing Cao
Kiang Wu Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 28, 2017
Study Start
May 23, 2017
Primary Completion
September 13, 2017
Study Completion
September 13, 2017
Last Updated
November 20, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share