NCT02296125 · OUTCOME

Duration of Response (DoR)

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-04-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression

What was measured

Duration of response was defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy.

Analysis population: The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.

Groups in this outcome

Osimertinib 80 mg (Global Cohort)

Randomized participants received Osimertinib 80 mg orally once daily (QD)

SoC EGFR-TKI (Global Cohort)

Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.

Osimertinib 80 mg (China Cohort)

Randomized participants received Osimertinib 80 mg orally once daily (QD)

SoC EGFR-TKI (China Cohort)

Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	279
SoC EGFR-TKI (Global Cohort)	277
Osimertinib 80 mg (China Cohort)	71
SoC EGFR-TKI (China Cohort)	65

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	17.2	Not reported	13.8	22.0	Not reported
SoC EGFR-TKI (Global Cohort)	8.5	Not reported	7.3	9.8	Not reported
Osimertinib 80 mg (China Cohort)	16.4	Not reported	12.3	NA	NA-Upper limit is not calculable at this data cut-off.
SoC EGFR-TKI (China Cohort)	10.9	Not reported	8.3	13.8	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
1.21
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.09
group Ids
OG002
OG003
non Inferiority Comment
The china cohort was not powered for superiority
non Inferiority Type
OTHER
p Value
0.0133
param Type
Mean Difference (Final Values)
param Value
2.48
statistical Method
Regression, Linear
ci Lower Limit
1.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.08
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Mean Difference (Final Values)
param Value
2.27
statistical Method
Regression, Linear

Complete source fields

analyses

ci Lower Limit
1.21
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.09
group Ids
OG002
OG003
non Inferiority Comment
The china cohort was not powered for superiority
non Inferiority Type
OTHER
p Value
0.0133
param Type
Mean Difference (Final Values)
param Value
2.48
statistical Method
Regression, Linear
ci Lower Limit
1.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.08
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Mean Difference (Final Values)
param Value
2.27
statistical Method
Regression, Linear

classes

categories
measurements
group Id
OG000
lower Limit
13.8
upper Limit
22.0
value
17.2
group Id
OG001
lower Limit
7.3
upper Limit
9.8
value
8.5
comment
NA-Upper limit is not calculable at this data cut-off.
group Id
OG002
lower Limit
12.3
upper Limit
NA
value
16.4
group Id
OG003
lower Limit
8.3
upper Limit
13.8
value
10.9

denoms

counts
group Id
OG000
value
279
group Id
OG001
value
277
group Id
OG002
value
71
group Id
OG003
value
65
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Randomized participants received Osimertinib 80 mg orally once daily (QD)
id
OG000
title
Osimertinib 80 mg (Global Cohort)
description
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
id
OG001
title
SoC EGFR-TKI (Global Cohort)
description
Randomized participants received Osimertinib 80 mg orally once daily (QD)
id
OG002
title
Osimertinib 80 mg (China Cohort)
description
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
id
OG003
title
SoC EGFR-TKI (China Cohort)

param Type

MEDIAN

population Description

The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.

reporting Status

POSTED

time Frame

At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression

title

Duration of Response (DoR)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice