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NCT04035486 · OUTCOME

Mean AUCss of AZ5104 (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
h*nmol/L
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Up to approximately 33 months after the first patient is randomized.

What was measured

AUCss is the area under the plasma concentration-time curve over a doing interval at a stead state.

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 + Chemo176
Randomized: AZD9291233

Reported measurements

Source class 1
Values in h*nmol/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo127754.72Not reportedNot reportedNot reported
Randomized: AZD9291117747.11Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.72
        value
        1277
      2. group Id
        OG001
        spread
        47.11
        value
        1177
denoms
  1. counts
    1. group Id
      OG000
      value
      176
    2. group Id
      OG001
      value
      233
    units
    Participants
description
AUCss is the area under the plasma concentration-time curve over a doing interval at a stead state.
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
Up to approximately 33 months after the first patient is randomized.
title
Mean AUCss of AZ5104 (Randomized Component)
type
SECONDARY
unit Of Measure
h*nmol/L

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

Preserved source evidence · Not medical advice