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NCT04644237 · OUTCOME

Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) · Source last updated 2025-11-21

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

Measure
MEAN
Unit
µg/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1; Cycle 2 Day 1, and Cycle 3 Day 1: pre- and post-dose; Cycle 1 Day 8: 7 days post-dose; Cycle 1 Day 15: 14 days post-dose; Cycle 4 Day 1 and Cycle 6 Day 1: pre-dose (each cycle is 21 days)

Analysis population: The PK Analysis Set included all randomized subjects who received at least one dose of study drug and had any measurable post-dose serum concentrations of T-DXd, total anti-HER2 antibody, and DXd.

Groups in this outcome

Trastuzumab Deruxtecan 5.4 mg/kg

Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).

Trastuzumab Deruxtecan 6.4 mg/kg

Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).

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

Analysis denominator · Participants

GroupSource count
Trastuzumab Deruxtecan 5.4 mg/kg101
Trastuzumab Deruxtecan 6.4 mg/kg50

Reported measurements

Trastuzumab Deruxtecan
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan 5.4 mg/kg14869.5Not reportedNot reportedNot reported
Trastuzumab Deruxtecan 6.4 mg/kg196184Not reportedNot reportedNot reported
Total Anti-HER2 Antibody
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan 5.4 mg/kg13857.8Not reportedNot reportedNot reported
Trastuzumab Deruxtecan 6.4 mg/kg179194Not reportedNot reportedNot reported
DXd (Metabolite Active Metabolite MAAA-1181a)
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan 5.4 mg/kg.015.007Not reportedNot reportedNot reported
Trastuzumab Deruxtecan 6.4 mg/kg.018.008Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        69.5
        value
        148
      2. group Id
        OG001
        spread
        184
        value
        196
    title
    Trastuzumab Deruxtecan
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.8
        value
        138
      2. group Id
        OG001
        spread
        194
        value
        179
    title
    Total Anti-HER2 Antibody
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        .007
        value
        .015
      2. group Id
        OG001
        spread
        .008
        value
        .018
    title
    DXd (Metabolite Active Metabolite MAAA-1181a)
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      50
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    OG000
    title
    Trastuzumab Deruxtecan 5.4 mg/kg
  2. description
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    OG001
    title
    Trastuzumab Deruxtecan 6.4 mg/kg
param Type
MEAN
population Description
The PK Analysis Set included all randomized subjects who received at least one dose of study drug and had any measurable post-dose serum concentrations of T-DXd, total anti-HER2 antibody, and DXd.
reporting Status
POSTED
time Frame
Cycle 1 Day 1; Cycle 2 Day 1, and Cycle 3 Day 1: pre- and post-dose; Cycle 1 Day 8: 7 days post-dose; Cycle 1 Day 15: 14 days post-dose; Cycle 4 Day 1 and Cycle 6 Day 1: pre-dose (each cycle is 21 days)
title
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
type
SECONDARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice