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NCT04644237 · OUTCOME

Progression-free Survival 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
MEDIAN
Unit
months
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

Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on blinded independent central review (BICR) and investigator assessment.

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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Deruxtecan 5.4 mg/kg9.7Not reported8.211.3Not reported
Trastuzumab Deruxtecan 6.4 mg/kg9.5Not reported6.515.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.2
        upper Limit
        11.3
        value
        9.7
      2. group Id
        OG001
        lower Limit
        6.5
        upper Limit
        15.1
        value
        9.5
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    2. group Id
      OG001
      value
      50
    units
    Participants
description
Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on blinded independent central review (BICR) and investigator assessment.
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
MEDIAN
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
Progression-free Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice