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An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer

NCT ID: NCT03457220

Last Updated: 2020-12-21

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

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-21

Study Completion Date

2019-12-31

Brief Summary

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AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Detailed Description

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AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* At least 20 years of age
* Patients who were in the AZD9291 Early Access Program
* Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents
* Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018
* Patients agree to provide the written informed consent or the informed consent is waived by IRB.

Exclusion Criteria

• Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC
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

Locations

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Research Site

Kaohsiung City, , Taiwan

Site Status

Research Site

Kaohsiung City, , Taiwan

Site Status

Research Site

Taichung, , Taiwan

Site Status

Research Site

Tainan City, , Taiwan

Site Status

Research Site

Tainan City, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5160R00021&attachmentIdentifier=d9ab5d4f-73bd-434e-9cb4-4205c318fd9e&fileName=D5160R00021_redacted_csr_synopsis.pdf&versionIdentifier=

CSR\_Synopsis

Other Identifiers

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D5160R00021

Identifier Type: -

Identifier Source: org_study_id