Clinical trial NCT03457220: An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 423
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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

Eligibility 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months
Other outcomes:
measure: Response Rate (RR)
timeFrame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
measure: Disease Control Rate (DCR)
timeFrame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
measure: Time to treatment discontinuation (TTD)
timeFrame: Time from patient first dose to data cut off (up to 32 months)
Locations:
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
References: