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NCT02296125 · OUTCOME

Plasma Concentrations of Metabolites AZ5104

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 AZ5104.

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 were non-quantifiable and not calculable
Osimertinib 80 mg (China Cohort)NANANot reportedNot reportedNA as the values were non-quantifiable and not calculable
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)0.1542230.5161Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)NANANot reportedNot reportedNA as the values were non-quantifiable and not calculable
Cycle 1 Day 1-3 - 5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)223
Osimertinib 80 mg (China Cohort)69
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)3.9399153.7651Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)6.3053123.9308Not 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)42.912350.2410Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)56.831951.0378Not 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)42.743452.8557Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)55.994759.1318Not 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)48.354750.4286Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)64.062154.2058Not 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)39.371856.6226Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)56.033057.5022Not 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)39.414555.3468Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)55.376755.9096Not 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)45.684254.3876Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)63.921656.4249Not 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)38.384750.0861Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)52.578651.0588Not 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)38.530149.6296Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)52.763847.4797Not 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)44.467048.4730Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)60.620150.6931Not 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)40.123047.0682Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)54.434951.3447Not 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)40.498747.6483Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)54.715854.6783Not 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)46.031044.6875Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)60.464952.6147Not 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)38.385948.5351Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)56.478259.1303Not 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)38.762048.1414Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)57.409557.0891Not 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)43.913550.6779Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)65.194358.5043Not 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)40.435647.2671Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)55.116254.3493Not reportedNot reportedNot reported
Cycle 13 Day 1, 0.5- 2 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)147
Osimertinib 80 mg (China Cohort)54
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)40.111646.3929Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)54.385849.9148Not reportedNot reportedNot reported
Cycle 13 Day 1, 3-5 hours

Analysis denominator · Participants

GroupSource count
Osimertinib 80 mg (Global Cohort)147
Osimertinib 80 mg (China Cohort)55
Values in Nano moles · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)45.908344.8309Not reportedNot reportedNot reported
Osimertinib 80 mg (China Cohort)61.742651.2924Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA as the values were non-quantifiable and not calculable
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        NA as the values were non-quantifiable and not calculable
        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
        230.5161
        value
        0.1542
      2. comment
        NA as the values were non-quantifiable and not calculable
        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
        153.7651
        value
        3.9399
      2. group Id
        OG001
        spread
        123.9308
        value
        6.3053
    denoms
    1. counts
      1. group Id
        OG000
        value
        223
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Cycle 1 Day 1-3 - 5 hours
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.2410
        value
        42.9123
      2. group Id
        OG001
        spread
        51.0378
        value
        56.8319
    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
        52.8557
        value
        42.7434
      2. group Id
        OG001
        spread
        59.1318
        value
        55.9947
    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
        50.4286
        value
        48.3547
      2. group Id
        OG001
        spread
        54.2058
        value
        64.0621
    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
        56.6226
        value
        39.3718
      2. group Id
        OG001
        spread
        57.5022
        value
        56.0330
    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
        55.3468
        value
        39.4145
      2. group Id
        OG001
        spread
        55.9096
        value
        55.3767
    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
        54.3876
        value
        45.6842
      2. group Id
        OG001
        spread
        56.4249
        value
        63.9216
    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
        50.0861
        value
        38.3847
      2. group Id
        OG001
        spread
        51.0588
        value
        52.5786
    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
        49.6296
        value
        38.5301
      2. group Id
        OG001
        spread
        47.4797
        value
        52.7638
    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
        48.4730
        value
        44.4670
      2. group Id
        OG001
        spread
        50.6931
        value
        60.6201
    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 AZ5104.
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 Metabolites AZ5104
type
SECONDARY
unit Of Measure
Nano moles

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Preserved source evidence · Not medical advice