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Report for Clinical Trial NCT03457220

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT03457220 Non Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma


Primary Outcomes

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

Measure: Progression free survival (PFS)

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

Secondary Outcomes

Description: 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

Measure: Overall survival (OS)

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

Other Outcomes

Description: 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

Measure: Response Rate (RR)

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

Description: 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.

Measure: Disease Control Rate (DCR)

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

Description: 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

Measure: Time to treatment discontinuation (TTD)

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

Time Perspective: Prospective

Other


There is one SNP

SNPs


1 T790M

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. --- T790M ---

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. --- T790M ---



HPO Nodes


HPO: