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NCT02296125 · OUTCOME

Plasma Concentrations of AZD9291

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: GEOMETRIC_MEAN
Unit: Nano moles
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months)

What was measured

To characterise the pharmacokinetics (PK) of osimertinib

Analysis population: The pharmacokinetic analysis set (osimertinib arm only) was defined as participants in the FAS who had at least 1 evaluable PK concentration and who had no detectable pre-dose osimertinib concentrations above the lower limit of quantitation (LLQ) on Cycle 1 Day 1.

Groups in this outcome

Osimertinib 80 mg (Global Cohort)

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

Osimertinib 80 mg (China Cohort)

Randomized participants received Osimertinib 80 mg orally once daily (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
Osimertinib 80 mg (China Cohort)	71

Reported measurements

Cycle 1 Day 1-Predose

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	199
Osimertinib 80 mg (China Cohort)	69

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	NA	NA	Not reported	Not reported	NA as values were not calculable and non-quantifiable
Osimertinib 80 mg (China Cohort)	NA	NA	Not reported	Not reported	NA as values were not calculable and non-quantifiable

Cycle 1 Day 1-0.5 - 2 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	203
Osimertinib 80 mg (China Cohort)	69

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	4.9487	1173.3679	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	5.0249	816.7305	Not reported	Not reported	Not reported

Cycle 1 Day 1-3 - 5 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	211
Osimertinib 80 mg (China Cohort)	69

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	129.3340	171.2983	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	131.5669	120.5979	Not reported	Not reported	Not reported

Cycle 3 Day 1- Predose

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	183
Osimertinib 80 mg (China Cohort)	67

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	394.3489	43.9296	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	441.5606	55.0039	Not reported	Not reported	Not reported

Cycle 3 Day 1, 0.5 - 2 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	183
Osimertinib 80 mg (China Cohort)	68

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	397.7406	45.8548	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	441.7343	60.0626	Not reported	Not reported	Not reported

Cycle 3 Day 1, 3 - 5 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	182
Osimertinib 80 mg (China Cohort)	67

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	512.4012	44.0653	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	553.8090	60.9883	Not reported	Not reported	Not reported

Cycle 5 Day 1, Predose

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	180
Osimertinib 80 mg (China Cohort)	67

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	358.5487	53.8212	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	419.5893	63.2507	Not reported	Not reported	Not reported

Cycle 5 Day 1, 0.5 - 2 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	177
Osimertinib 80 mg (China Cohort)	67

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	369.0696	51.3284	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	426.8197	60.3841	Not reported	Not reported	Not reported

Cycle 5 Day 1, 3-5 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	179
Osimertinib 80 mg (China Cohort)	67

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	485.8142	47.2759	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	570.7729	61.4401	Not reported	Not reported	Not reported

Cycle 7 Day 1-Predose

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	181
Osimertinib 80 mg (China Cohort)	62

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	347.6176	47.7442	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	397.5857	54.9006	Not reported	Not reported	Not reported

Cycle 7 Day 1-0.5 - 2 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	179
Osimertinib 80 mg (China Cohort)	61

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	357.8529	45.0713	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	411.6170	49.4107	Not reported	Not reported	Not reported

Cycle 7 Day 1-3-5 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	179
Osimertinib 80 mg (China Cohort)	62

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	475.6587	41.5778	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	530.7212	56.5184	Not reported	Not reported	Not reported

Cycle 9 Day 1-Predose

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	165
Osimertinib 80 mg (China Cohort)	62

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	359.5284	47.0592	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	383.2238	67.7153	Not reported	Not reported	Not reported

Cycle 9 Day 1-0.5-2 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	165
Osimertinib 80 mg (China Cohort)	61

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	363.0106	48.3837	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	395.2179	71.5532	Not reported	Not reported	Not reported

Cycle 9 Day 1-3-5 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	163
Osimertinib 80 mg (China Cohort)	62

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	485.6006	46.6459	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	490.5964	70.3383	Not reported	Not reported	Not reported

Cycle 11 Day 1-Predose

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	158
Osimertinib 80 mg (China Cohort)	59

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	354.5330	44.4308	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	410.4023	66.2329	Not reported	Not reported	Not reported

Cycle 11 Day 1-0.5 -2 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	160
Osimertinib 80 mg (China Cohort)	59

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	367.7450	45.2003	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	415.2427	64.6174	Not reported	Not reported	Not reported

Cycle 11 Day 1-3-5 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	161
Osimertinib 80 mg (China Cohort)	59

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	476.4472	44.4457	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	528.8081	68.4645	Not reported	Not reported	Not reported

Cycle 13 Day 1-Predose

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	150
Osimertinib 80 mg (China Cohort)	55

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	369.9834	40.1071	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	404.2678	62.0291	Not reported	Not reported	Not reported

Cycle 13 Day 1-0.5 -2 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	147
Osimertinib 80 mg (China Cohort)	54

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	371.4157	42.9794	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	393.1688	62.1053	Not reported	Not reported	Not reported

Cycle 13 Day 1-3-5 hours

Analysis denominator · Participants

Group	Source count
Osimertinib 80 mg (Global Cohort)	147
Osimertinib 80 mg (China Cohort)	55

Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Osimertinib 80 mg (Global Cohort)	496.6866	40.8757	Not reported	Not reported	Not reported
Osimertinib 80 mg (China Cohort)	499.0220	62.5485	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
NA as values were not calculable and non-quantifiable
group Id
OG000
spread
NA
value
NA
comment
NA as values were not calculable and non-quantifiable
group Id
OG001
spread
NA
value
NA
denoms
counts
group Id
OG000
value
199
group Id
OG001
value
69
units
Participants
title
Cycle 1 Day 1-Predose
categories
measurements
group Id
OG000
spread
1173.3679
value
4.9487
group Id
OG001
spread
816.7305
value
5.0249
denoms
counts
group Id
OG000
value
203
group Id
OG001
value
69
units
Participants
title
Cycle 1 Day 1-0.5 - 2 hours
categories
measurements
group Id
OG000
spread
171.2983
value
129.3340
group Id
OG001
spread
120.5979
value
131.5669
denoms
counts
group Id
OG000
value
211
group Id
OG001
value
69
units
Participants
title
Cycle 1 Day 1-3 - 5 hours
categories
measurements
group Id
OG000
spread
43.9296
value
394.3489
group Id
OG001
spread
55.0039
value
441.5606
denoms
counts
group Id
OG000
value
183
group Id
OG001
value
67
units
Participants
title
Cycle 3 Day 1- Predose
categories
measurements
group Id
OG000
spread
45.8548
value
397.7406
group Id
OG001
spread
60.0626
value
441.7343
denoms
counts
group Id
OG000
value
183
group Id
OG001
value
68
units
Participants
title
Cycle 3 Day 1, 0.5 - 2 hours
categories
measurements
group Id
OG000
spread
44.0653
value
512.4012
group Id
OG001
spread
60.9883
value
553.8090
denoms
counts
group Id
OG000
value
182
group Id
OG001
value
67
units
Participants
title
Cycle 3 Day 1, 3 - 5 hours
categories
measurements
group Id
OG000
spread
53.8212
value
358.5487
group Id
OG001
spread
63.2507
value
419.5893
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
67
units
Participants
title
Cycle 5 Day 1, Predose
categories
measurements
group Id
OG000
spread
51.3284
value
369.0696
group Id
OG001
spread
60.3841
value
426.8197
denoms
counts
group Id
OG000
value
177
group Id
OG001
value
67
units
Participants
title
Cycle 5 Day 1, 0.5 - 2 hours
categories
measurements
group Id
OG000
spread
47.2759
value
485.8142
group Id
OG001
spread
61.4401
value
570.7729
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
67
units
Participants
title
Cycle 5 Day 1, 3-5 hours
categories
measurements
group Id
OG000
spread
47.7442
value
347.6176
group Id
OG001
spread
54.9006
value
397.5857
denoms
counts
group Id
OG000
value
181
group Id
OG001
value
62
units
Participants
title
Cycle 7 Day 1-Predose
categories
measurements
group Id
OG000
spread
45.0713
value
357.8529
group Id
OG001
spread
49.4107
value
411.6170
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
61
units
Participants
title
Cycle 7 Day 1-0.5 - 2 hours
categories
measurements
group Id
OG000
spread
41.5778
value
475.6587
group Id
OG001
spread
56.5184
value
530.7212
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
62
units
Participants
title
Cycle 7 Day 1-3-5 hours

denoms

counts
group Id
OG000
value
279
group Id
OG001
value
71
units
Participants

description

To characterise the pharmacokinetics (PK) of osimertinib

dispersion Type

Geometric Coefficient of Variation

groups

description
Randomized participants received Osimertinib 80 mg orally once daily (QD)
id
OG000
title
Osimertinib 80 mg (Global Cohort)
description
Randomized participants received Osimertinib 80 mg orally once daily (QD)
id
OG001
title
Osimertinib 80 mg (China Cohort)

param Type

GEOMETRIC_MEAN

population Description

The pharmacokinetic analysis set (osimertinib arm only) was defined as participants in the FAS who had at least 1 evaluable PK concentration and who had no detectable pre-dose osimertinib concentrations above the lower limit of quantitation (LLQ) on Cycle 1 Day 1.

reporting Status

POSTED

time Frame

Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months)

title

Plasma Concentrations of AZD9291

type

SECONDARY

unit Of Measure

Nano moles

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

Preserved source evidence · Not medical advice