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NCT04644237 · OUTCOME

Disease Control Rate Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
9 months after the last participant is randomized or later to data cut off, up to approximately 35 months

What was measured

Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Analysis population: Full Analysis Set includes all subjects for whom study treatment was assigned by randomization

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/kg102
Trastuzumab Deruxtecan 6.4 mg/kg50

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan 5.4 mg/kg90.2Not reported82.795.2Not reported
Trastuzumab Deruxtecan 6.4 mg/kg88.0Not reported75.795.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82.7
        upper Limit
        95.2
        value
        90.2
      2. group Id
        OG001
        lower Limit
        75.7
        upper Limit
        95.5
        value
        88.0
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    2. group Id
      OG001
      value
      50
    units
    Participants
description
Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
reporting Status
POSTED
time Frame
9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
title
Disease Control Rate Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice