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NCT Number: NCT03457220

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

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

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Kaohsiung City, Taiwan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months

    PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months

    OS is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of death due to any cause

Other outcomes

  1. Response Rate (RR)

    Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months

    RR is defined as the percentage of subjects with the best overall response of 'responding', which is defined as complete response (CR) or partial response (PR), by investigator's assessment

  2. Disease Control Rate (DCR)

    Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months

    DCR is defined as the percentages of subjects who have the best overall response of CR, PR, or SD, which is determined by investigator's assessment.

  3. Time to treatment discontinuation (TTD)

    Time frame: Time from patient first dose to data cut off (up to 32 months)

    TTD is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of the single use of AZD9291 discontinuation for any reason

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Observational Study to Evaluate AZD9291 Treatment in Patients With EGFR T790M Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Following Progression on at Least One Prior EGFR TKI Treatment

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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