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NCT04035486 · OUTCOME

Plasma Concentration of Metabolite AZ5104 When Osimertinib is Given With or Without Chemotherapy (Randomized Component)

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) · Source last updated 2026-09-03

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

Measure
GEOMETRIC_MEAN
Unit
nM
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose and 1-hour post-dose on Day 22; pre-dose, 1-, 2-, 4-, and 6-hours post-dose on Day 43; pre-dose and 1-hour post-dose on Day 106.

What was measured

An analysis will be performed to assess whether the plasma concentration of metabolite AZ5104 is affected when given with or without chemotherapy. Samples were collected pre-dose and 1-hour post-dose on day 22 and day 106; on day 43 samples were collected pre-dose and 1-, 2-, 4-, and 6-hours post-dose.

Analysis population: Pharmacokinetic Analysis Set, includes all randomized participants that received at least 1 dose of study treatment, have at least 1 measurable PK concentration and no missing doses 7 days prior to the PK sample, without any protocol deviation that affects PK, supported by the relevant date and time of this sample.

Groups in this outcome

Randomized: AZD9291 + Chemo

Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W

Randomized: AZD9291

Osimertinib (AZD9291) 80mg 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
Randomized: AZD9291 + Chemo244
Randomized: AZD9291263

Reported measurements

Day 22, pre-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo217
Randomized: AZD9291252
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo51.7482.11Not reportedNot reportedNot reported
Randomized: AZD929152.4256.28Not reportedNot reportedNot reported
Day 22, 1-hour post-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo221
Randomized: AZD9291254
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo49.5681.57Not reportedNot reportedNot reported
Randomized: AZD929152.7856.56Not reportedNot reportedNot reported
Day 43, pre-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo206
Randomized: AZD9291252
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo47.7780.80Not reportedNot reportedNot reported
Randomized: AZD929143.8961.54Not reportedNot reportedNot reported
Day 43, 1-hour post-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo208
Randomized: AZD9291252
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo46.4880.00Not reportedNot reportedNot reported
Randomized: AZD929144.8960.66Not reportedNot reportedNot reported
Day 43, 2-hour post-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo195
Randomized: AZD9291239
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo49.1971.52Not reportedNot reportedNot reported
Randomized: AZD929147.1456.20Not reportedNot reportedNot reported
Day 43, 4-hour post-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo192
Randomized: AZD9291237
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo52.4467.61Not reportedNot reportedNot reported
Randomized: AZD929150.9254.33Not reportedNot reportedNot reported
Day 43, 6-hour post-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo187
Randomized: AZD9291237
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo53.0465.94Not reportedNot reportedNot reported
Randomized: AZD929150.8953.01Not reportedNot reportedNot reported
Day 106, pre-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo150
Randomized: AZD9291227
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo47.3364.86Not reportedNot reportedNot reported
Randomized: AZD929141.0957.71Not reportedNot reportedNot reported
Day 106, 1-hour post-dose

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo148
Randomized: AZD9291223
Values in nM · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo47.1765.49Not reportedNot reportedNot reported
Randomized: AZD929141.3057.60Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.11
        value
        51.74
      2. group Id
        OG001
        spread
        56.28
        value
        52.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        217
      2. group Id
        OG001
        value
        252
      units
      Participants
    title
    Day 22, pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        81.57
        value
        49.56
      2. group Id
        OG001
        spread
        56.56
        value
        52.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        221
      2. group Id
        OG001
        value
        254
      units
      Participants
    title
    Day 22, 1-hour post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        80.80
        value
        47.77
      2. group Id
        OG001
        spread
        61.54
        value
        43.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        206
      2. group Id
        OG001
        value
        252
      units
      Participants
    title
    Day 43, pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        80.00
        value
        46.48
      2. group Id
        OG001
        spread
        60.66
        value
        44.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        208
      2. group Id
        OG001
        value
        252
      units
      Participants
    title
    Day 43, 1-hour post-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        71.52
        value
        49.19
      2. group Id
        OG001
        spread
        56.20
        value
        47.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        195
      2. group Id
        OG001
        value
        239
      units
      Participants
    title
    Day 43, 2-hour post-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.61
        value
        52.44
      2. group Id
        OG001
        spread
        54.33
        value
        50.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        192
      2. group Id
        OG001
        value
        237
      units
      Participants
    title
    Day 43, 4-hour post-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.94
        value
        53.04
      2. group Id
        OG001
        spread
        53.01
        value
        50.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        187
      2. group Id
        OG001
        value
        237
      units
      Participants
    title
    Day 43, 6-hour post-dose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.86
        value
        47.33
      2. group Id
        OG001
        spread
        57.71
        value
        41.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        150
      2. group Id
        OG001
        value
        227
      units
      Participants
    title
    Day 106, pre-dose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.49
        value
        47.17
      2. group Id
        OG001
        spread
        57.60
        value
        41.30
    denoms
    1. counts
      1. group Id
        OG000
        value
        148
      2. group Id
        OG001
        value
        223
      units
      Participants
    title
    Day 106, 1-hour post-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      244
    2. group Id
      OG001
      value
      263
    units
    Participants
description
An analysis will be performed to assess whether the plasma concentration of metabolite AZ5104 is affected when given with or without chemotherapy. Samples were collected pre-dose and 1-hour post-dose on day 22 and day 106; on day 43 samples were collected pre-dose and 1-, 2-, 4-, and 6-hours post-dose.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
    id
    OG000
    title
    Randomized: AZD9291 + Chemo
  2. description
    Osimertinib (AZD9291) 80mg QD.
    id
    OG001
    title
    Randomized: AZD9291
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic Analysis Set, includes all randomized participants that received at least 1 dose of study treatment, have at least 1 measurable PK concentration and no missing doses 7 days prior to the PK sample, without any protocol deviation that affects PK, supported by the relevant date and time of this sample.
reporting Status
POSTED
time Frame
Pre-dose and 1-hour post-dose on Day 22; pre-dose, 1-, 2-, 4-, and 6-hours post-dose on Day 43; pre-dose and 1-hour post-dose on Day 106.
title
Plasma Concentration of Metabolite AZ5104 When Osimertinib is Given With or Without Chemotherapy (Randomized Component)
type
SECONDARY
unit Of Measure
nM

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

Preserved source evidence · Not medical advice