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NCT03505710 · OUTCOME

Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer · Source last updated 2025-05-30

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
From screening to documented tumor progression or death from any cause, up to 36 months (data cut-off)

What was measured

Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported.

Analysis population: Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 03 May 2021.

Groups in this outcome

Cohort 1: HER2 Overexpressing

Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.

Cohort 1a: HER2 Overexpressing

Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.

Cohort 2: HER2 Mutated

Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.

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

Analysis denominator · Participants

GroupSource count
Cohort 1: HER2 Overexpressing13
Cohort 1a: HER2 Overexpressing12
Cohort 2: HER2 Mutated50

Reported measurements

Independent Central Review

Analysis denominator · Participants

GroupSource count
Cohort 1: HER2 Overexpressing13
Cohort 1a: HER2 Overexpressing12
Cohort 2: HER2 Mutated50
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: HER2 Overexpressing5.8Not reported4.3NAUpper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
Cohort 1a: HER2 Overexpressing4.7Not reported4.0NAUpper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
Cohort 2: HER2 Mutated9.3Not reported5.714.7Not reported
Investigator Assessment

Analysis denominator · Participants

GroupSource count
Cohort 1: HER2 Overexpressing11
Cohort 1a: HER2 Overexpressing3
Cohort 2: HER2 Mutated30
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: HER2 Overexpressing5.8Not reported4.711.3Not reported
Cohort 1a: HER2 Overexpressing7.0Not reported4.2NAUpper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
Cohort 2: HER2 Mutated11.7Not reported7.216.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
        group Id
        OG000
        lower Limit
        4.3
        upper Limit
        NA
        value
        5.8
      2. comment
        Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
        group Id
        OG001
        lower Limit
        4.0
        upper Limit
        NA
        value
        4.7
      3. group Id
        OG002
        lower Limit
        5.7
        upper Limit
        14.7
        value
        9.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        50
      units
      Participants
    title
    Independent Central Review
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.7
        upper Limit
        11.3
        value
        5.8
      2. comment
        Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
        group Id
        OG001
        lower Limit
        4.2
        upper Limit
        NA
        value
        7.0
      3. group Id
        OG002
        lower Limit
        7.2
        upper Limit
        16.9
        value
        11.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        30
      units
      Participants
    title
    Investigator Assessment
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      50
    units
    Participants
description
Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
    id
    OG000
    title
    Cohort 1: HER2 Overexpressing
  2. description
    Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
    id
    OG001
    title
    Cohort 1a: HER2 Overexpressing
  3. description
    Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
    id
    OG002
    title
    Cohort 2: HER2 Mutated
param Type
MEDIAN
population Description
Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 03 May 2021.
reporting Status
POSTED
time Frame
From screening to documented tumor progression or death from any cause, up to 36 months (data cut-off)
title
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Independent clinical review pending · Not medical advice