D5160C00022

AstraZeneca

Södertälje, Södertälje, Sweden, 151 85

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com

No

No

No

Final

10 Feb 2021

No

Yes

18 Apr 2019

No

To assess the efficacy and safety of single agent AZD9291 in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy.

The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples.

18 Sep 2015

No

No

Argentina: 30

Australia: 31

Austria: 46

Belgium: 31

Brazil: 88

Canada: 99

China: 1350

Denmark: 6

Ireland: 10

Italy: 510

Saudi Arabia: 3

Korea, Republic of: 466

Spain: 131

Sweden: 7

Taiwan: 188

United Kingdom: 18

3014

741

0

0

0

0

0

0

1798

1185

31

Overall Study (overall period)

Not applicable

Osimertinib

AZD9291

Tablet

Oral use

All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities).

Osimertinib

Osimertinib

OS was defined as the time, in months from the date of first dose of Osimertinib until death due to any cause, or at last documented contact with participant status “alive” (in this study any participants alive at study discontinuation, or lost to follow-up was considered being censored at study discontinuation date or at the last known date participant was alive). OS was summarized using a Kaplan-Meier (KM) estimate of the median time to death or censoring together with their 95% confidence intervals.

Primary

From the date of first dose of Osimertinib until the date of death (due to any cause) or last participant contact [up to 43 months]

Safety assessment of Osimertinib was analyzed by evaluating SAEs, AEs leading to dose modification, AEs leading to discontinuation, AESIs.

Primary

From screening to progession follow-up [every 6 weeks (± 1 week) relative to the date of enrolment until end of study]

PFS was defined as the time, in months from first dose of Osimertinib until the date of disease progression or death in the absence of progression. Participants who had not progressed or died at study discontinuation were censored at the time of the latest date of disease assessment. PFS was summarized using KM estimates of the median time to progression or death with their 95% confidence intervals.

Secondary

From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]

TTD or death was assessed as a supportive summary to PFS and defined as the time from the date of the first dose of osimertinib in the study until the date of osimertinib discontinuation or death, regardless of the reason for discontinuation. TTD was summarized using KM estimates of the median times to progression or death or treatment discontinuation.

Secondary

From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]

RR was defined as the number (%) of participants with a best response (by Investigator assessment) of ‘responding’, regardless of the method of evaluation, and was based on a subset of the full analysis set consisting of subjects with at least one documented response assessment. RR was summarised together with the 95% CI.

Secondary

From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]

From screening to progession follow-up [every 6 weeks (± 1 week) relative to the date of enrolment until end of study]

Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) [Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected.

23.1

Osimertinib