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).

To assess the effectiveness and safety of osimertinib treatment in a real world setting.

Study Overview

• Status: Completed
• Conditions: T790M Positive NSCLC Patients
• Intervention / Treatment: Drug: osimertinib

Detailed Description

The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• China
  • Macau, China
    • Kiang Wu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed after EGFR TKI treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EGFR T790M Patients; Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI	Drug: osimertinib; Oral dose of 80mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	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	Followed up 10 months after last subject in
T790M mutation testing time	Average turnaround time.	Within 14 days after enrollment date
Treatment patterns	To assess by number of previous adopted/current/future therapies as recorded on the case report form	Followed up 10 months after last patient in
Adverse events	To assess by number of adverse events as recorded on the case report form.	Follow up 10 months after last patient in.
Adverse event intensity	To assess by intensity of adverse events as recorded on the case report form, which will be measured by CTCAE grade system	Follow up 10 months after last patient in.
T790M mutation testing sample	To assess by proportion of testing samples types as recorded on the case report form.	Within 14 days after enrollment date
T790M mutation testing platform	To assess by proportion of each testing platform as recorded on the case report form.	Within 14 days after enrollment date
EGFR testing mutation subtype	To assess by proportion of EGFR mutation subtype as recorded on the case report form	Within 14 days after enrollment date

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Yabing Cao, Kiang Wu Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2017
• Primary Completion (ACTUAL): September 13, 2017
• Study Completion (ACTUAL): September 13, 2017

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: D5160R00016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes