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NCT03456076 · OUTCOME

Plasma Concentration of Alectinib Metabolite M4

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer · Source last updated 2026-07-15

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose (2 hours) Week 3 - Week 96

Analysis population: The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.

Groups in this outcome

Alectinib

Participants received 600 mg oral alectinib twice daily (BID) for 2 years

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Alectinib124

Reported measurements

Week 3

Analysis denominator · Participants

GroupSource count
Alectinib119
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib178111.7Not reportedNot reportedNot reported
Week 6

Analysis denominator · Participants

GroupSource count
Alectinib119
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib21486.3Not reportedNot reportedNot reported
Week 9

Analysis denominator · Participants

GroupSource count
Alectinib116
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib21378.9Not reportedNot reportedNot reported
Week 12

Analysis denominator · Participants

GroupSource count
Alectinib115
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib20594.7Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
Alectinib111
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib23773.2Not reportedNot reportedNot reported
Week 36

Analysis denominator · Participants

GroupSource count
Alectinib107
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib23850.7Not reportedNot reportedNot reported
Week 48

Analysis denominator · Participants

GroupSource count
Alectinib102
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib20951.7Not reportedNot reportedNot reported
Week 60

Analysis denominator · Participants

GroupSource count
Alectinib102
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib21749.7Not reportedNot reportedNot reported
Week 72

Analysis denominator · Participants

GroupSource count
Alectinib97
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib21362.6Not reportedNot reportedNot reported
Week 84

Analysis denominator · Participants

GroupSource count
Alectinib81
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib19865.4Not reportedNot reportedNot reported
Week 96

Analysis denominator · Participants

GroupSource count
Alectinib68
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib19176.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        111.7
        value
        178
    denoms
    1. counts
      1. group Id
        OG000
        value
        119
      units
      Participants
    title
    Week 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        86.3
        value
        214
    denoms
    1. counts
      1. group Id
        OG000
        value
        119
      units
      Participants
    title
    Week 6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        78.9
        value
        213
    denoms
    1. counts
      1. group Id
        OG000
        value
        116
      units
      Participants
    title
    Week 9
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        94.7
        value
        205
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      units
      Participants
    title
    Week 12
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        73.2
        value
        237
    denoms
    1. counts
      1. group Id
        OG000
        value
        111
      units
      Participants
    title
    Week 24
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.7
        value
        238
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      units
      Participants
    title
    Week 36
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.7
        value
        209
    denoms
    1. counts
      1. group Id
        OG000
        value
        102
      units
      Participants
    title
    Week 48
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.7
        value
        217
    denoms
    1. counts
      1. group Id
        OG000
        value
        102
      units
      Participants
    title
    Week 60
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.6
        value
        213
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    Week 72
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.4
        value
        198
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Week 84
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.8
        value
        191
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    Week 96
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received 600 mg oral alectinib twice daily (BID) for 2 years
    id
    OG000
    title
    Alectinib
param Type
GEOMETRIC_MEAN
population Description
The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.
reporting Status
POSTED
time Frame
Predose (2 hours) Week 3 - Week 96
title
Plasma Concentration of Alectinib Metabolite M4
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice