Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC

NCT ID: NCT03133234

Last Updated: 2018-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-23

Study Completion Date

2017-09-13

Brief Summary

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

Detailed Description

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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.

Conditions

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T790M Positive NSCLC Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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EGFR T790M Patients

Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI

osimertinib

Intervention Type DRUG

Oral dose of 80mg once daily

Interventions

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osimertinib

Oral dose of 80mg once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yabing Cao

Role: PRINCIPAL_INVESTIGATOR

Kiang Wu Hospital

Locations

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Kiang Wu Hospital

Macau, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 31442277 (View on PubMed)

Other Identifiers

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D5160R00016

Identifier Type: -

Identifier Source: org_study_id

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