NCT02296125 · OUTCOME

Depth of Response

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: MEAN
Unit: percentage of change
Interval / dispersion: Standard Deviation
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

The Depth of response was defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions (TLs) at the nadir, in the absence of new lesions (NLs) or progression of Non-target lesions (NTLs), compared to baseline 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 percentage of change · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	-52.36	25.065	Not reported	Not reported	Not reported
SoC EGFR-TKI (Global Cohort)	-45.66	28.270	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	-49.17	24.303	Not reported	Not reported	Not reported
SoC EGFR-TKI (China Cohort)	-42.92	26.814	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
-11.205
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
-2.403
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0025
param Type
Mean Difference (Final Values)
param Value
-6.80
statistical Method
Regression, Linear
ci Lower Limit
-15.246
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.072
group Ids
OG002
OG003
non Inferiority Comment
The china cohort was not powered for superiority
non Inferiority Type
OTHER
p Value
0.1348
param Type
Mean Difference (Final Values)
param Value
-6.59
statistical Method
Regression, Linear

Complete source fields

analyses

ci Lower Limit
-11.205
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
-2.403
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0025
param Type
Mean Difference (Final Values)
param Value
-6.80
statistical Method
Regression, Linear
ci Lower Limit
-15.246
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.072
group Ids
OG002
OG003
non Inferiority Comment
The china cohort was not powered for superiority
non Inferiority Type
OTHER
p Value
0.1348
param Type
Mean Difference (Final Values)
param Value
-6.59
statistical Method
Regression, Linear

classes

categories
measurements
group Id
OG000
spread
25.065
value
-52.36
group Id
OG001
spread
28.270
value
-45.66
group Id
OG002
spread
24.303
value
-49.17
group Id
OG003
spread
26.814
value
-42.92

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

Standard Deviation

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

MEAN

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

Depth of Response

type

SECONDARY

unit Of Measure

percentage of change

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice