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NCT02296125 · OUTCOME

Plasma Concentrations of Metabolite AZ7550

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 metabolite AZ7550.

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

GroupSource count
Osimertinib 80 mg (Global Cohort)279
Osimertinib 80 mg (China Cohort)71

Reported measurements

Cycle 1 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)207
Osimertinib 80 mg (China Cohort)69
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)NANANot reportedNot reportedNA as the values are not calculable and non-quantifiable.
Osimertinib 80 mg (China Cohort)NANANot reportedNot reportedNA as the values are not calculable and non-quantifiable.
Cycle 1 Day 1, 0.5 - 2 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)207
Osimertinib 80 mg (China Cohort)69
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)0.1437168.2087Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)NANANot reportedNot reportedNA as the values are not calculable and non-quantifiable.
Cycle 1 Day 1, 3 - 5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)219
Osimertinib 80 mg (China Cohort)66
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)1.8610147.4624Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)2.1876123.6012Not reportedNot reportedNot reported
Cycle 3 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)183
Osimertinib 80 mg (China Cohort)67
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)46.128645.1082Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)55.995850.5705Not reportedNot reportedNot reported
Cycle 3 Day 1, 0.5 - 2 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)183
Osimertinib 80 mg (China Cohort)68
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)46.004545.9584Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)55.675453.0925Not reportedNot reportedNot reported
Cycle 3 Day 1, 3 - 5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)182
Osimertinib 80 mg (China Cohort)67
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)51.718245.3240Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)62.349353.5513Not reportedNot reportedNot reported
Cycle 5 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)181
Osimertinib 80 mg (China Cohort)67
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)44.453754.9882Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)53.043452.2936Not reportedNot reportedNot reported
Cycle 5 Day 1, 0.5 - 2 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)178
Osimertinib 80 mg (China Cohort)67
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)45.218651.6418Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)53.190151.5506Not reportedNot reportedNot reported
Cycle 5 Day 1, 3-5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)180
Osimertinib 80 mg (China Cohort)67
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)51.401851.3627Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)62.521851.0627Not reportedNot reportedNot reported
Cycle 7 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)181
Osimertinib 80 mg (China Cohort)62
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)46.291249.8713Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)53.416750.8399Not reportedNot reportedNot reported
Cycle 7 Day 1, 0.5-2 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)179
Osimertinib 80 mg (China Cohort)61
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)46.354049.0845Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)54.394246.1253Not reportedNot reportedNot reported
Cycle 7 Day 1,3-5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)179
Osimertinib 80 mg (China Cohort)62
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)52.353347.6489Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)61.900451.6117Not reportedNot reportedNot reported
Cycle 9 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)165
Osimertinib 80 mg (China Cohort)62
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)49.605845.5050Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)54.820750.2534Not reportedNot reportedNot reported
Cycle 9 Day 1, 0.5-2 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)165
Osimertinib 80 mg (China Cohort)61
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)49.938146.4568Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)55.243752.5736Not reportedNot reportedNot reported
Cycle 9 Day 1, 3-5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)163
Osimertinib 80 mg (China Cohort)62
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)56.535445.6736Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)60.893350.3474Not reportedNot reportedNot reported
Cycle 11 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)158
Osimertinib 80 mg (China Cohort)59
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)50.971046.8840Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)56.464351.2351Not reportedNot reportedNot reported
Cycle 11 Day 1, 0.5- 2 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)160
Osimertinib 80 mg (China Cohort)59
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)51.977345.3186Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)57.477847.3639Not reportedNot reportedNot reported
Cycle 11 Day 1, 3- 5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)161
Osimertinib 80 mg (China Cohort)59
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)57.698648.2382Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)65.305349.6916Not reportedNot reportedNot reported
Cycle 13 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)150
Osimertinib 80 mg (China Cohort)55
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)54.523843.8481Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)56.066651.2464Not reportedNot reportedNot reported
Cycle 13 Day 1, 0.5-2 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)146
Osimertinib 80 mg (China Cohort)54
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)54.122443.7869Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)56.875047.4338Not reportedNot reportedNot reported
Cycle 13 Day 1, 3-5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)146
Osimertinib 80 mg (China Cohort)55
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)61.605342.2947Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)63.336546.3082Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA as the values are not calculable and non-quantifiable.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        NA as the values are not calculable and non-quantifiable.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        207
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Cycle 1 Day 1, Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        168.2087
        value
        0.1437
      2. comment
        NA as the values are not calculable and non-quantifiable.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        207
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Cycle 1 Day 1, 0.5 - 2 hours
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        147.4624
        value
        1.8610
      2. group Id
        OG001
        spread
        123.6012
        value
        2.1876
    denoms
    1. counts
      1. group Id
        OG000
        value
        219
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    Cycle 1 Day 1, 3 - 5 hours
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.1082
        value
        46.1286
      2. group Id
        OG001
        spread
        50.5705
        value
        55.9958
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Cycle 3 Day 1, Predose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.9584
        value
        46.0045
      2. group Id
        OG001
        spread
        53.0925
        value
        55.6754
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    Cycle 3 Day 1, 0.5 - 2 hours
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.3240
        value
        51.7182
      2. group Id
        OG001
        spread
        53.5513
        value
        62.3493
    denoms
    1. counts
      1. group Id
        OG000
        value
        182
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Cycle 3 Day 1, 3 - 5 hours
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.9882
        value
        44.4537
      2. group Id
        OG001
        spread
        52.2936
        value
        53.0434
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Cycle 5 Day 1, Predose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.6418
        value
        45.2186
      2. group Id
        OG001
        spread
        51.5506
        value
        53.1901
    denoms
    1. counts
      1. group Id
        OG000
        value
        178
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Cycle 5 Day 1, 0.5 - 2 hours
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.3627
        value
        51.4018
      2. group Id
        OG001
        spread
        51.0627
        value
        62.5218
    denoms
    1. counts
      1. group Id
        OG000
        value
        180
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Cycle 5 Day 1, 3-5 hours
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.8713
        value
        46.2912
      2. group Id
        OG001
        spread
        50.8399
        value
        53.4167
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    Cycle 7 Day 1, Predose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.0845
        value
        46.3540
      2. group Id
        OG001
        spread
        46.1253
        value
        54.3942
    denoms
    1. counts
      1. group Id
        OG000
        value
        179
      2. group Id
        OG001
        value
        61
      units
      Participants
    title
    Cycle 7 Day 1, 0.5-2 hours
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.6489
        value
        52.3533
      2. group Id
        OG001
        spread
        51.6117
        value
        61.9004
    denoms
    1. counts
      1. group Id
        OG000
        value
        179
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    Cycle 7 Day 1,3-5 hours
denoms
  1. counts
    1. group Id
      OG000
      value
      279
    2. group Id
      OG001
      value
      71
    units
    Participants
description
To characterise the pharmacokinetics (PK) of osimertinib metabolite AZ7550.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Randomized participants received Osimertinib 80 mg orally once daily (QD)
    id
    OG000
    title
    Osimertinib 80 mg (Global Cohort)
  2. 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 Metabolite AZ7550
type
SECONDARY
unit Of Measure
Nano moles

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Preserved source evidence · Not medical advice