Skip to content
TriangleGet started
← Full study record

NCT03505710 · OUTCOME

Overall Survival (OS) 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 date of enrollment to death from any cause, up to 36 months (data cut-off)

What was measured

Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.

Analysis population: Overall survival (OS) was assessed in the Full Analysis Set 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 Overexpressing49
Cohort 1a: HER2 Overexpressing41
Cohort 2: HER2 Mutated91

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: HER2 Overexpressing12.4Not reported7.817.2Not reported
Cohort 1a: HER2 OverexpressingNANot reported6.7NAMedian OS and upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
Cohort 2: HER2 Mutated17.8Not reported13.822.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.8
        upper Limit
        17.2
        value
        12.4
      2. comment
        Median OS and upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
        group Id
        OG001
        lower Limit
        6.7
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        13.8
        upper Limit
        22.1
        value
        17.8
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      41
    3. group Id
      OG002
      value
      91
    units
    Participants
description
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
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
Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.
reporting Status
POSTED
time Frame
From date of enrollment to death from any cause, up to 36 months (data cut-off)
title
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
type
SECONDARY
unit Of Measure
months

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

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