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

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ClinicalTrials.gov Identifier: NCT03457220
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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

Condition or disease
Non Small Cell Lung Cancer

Detailed Description:
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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Study Type : Observational
Actual Enrollment : 423 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All the available patients who have participated in the AZD9291 EAP will be screened for the eligible criteria for data collection in this observational study
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457220


Locations
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Taiwan
Research Site
Kaohsiung, Taiwan, 807
Research Site
Kaohsiung, Taiwan, 83301
Research Site
Taichung, Taiwan, 40705
Research Site
Tainan City, Taiwan, 70403
Research Site
Tainan City, Taiwan, 73657
Research Site
Taipei, Taiwan, 10002
Research Site
Taipei, Taiwan, 112
Sponsors and Collaborators
AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03457220    
Other Study ID Numbers: D5160R00021
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms