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NCT04484142 · OUTCOME

Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR)

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) · Source last updated 2026-03-24

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
From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.

What was measured

ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Analysis population: Outcome Measure was assessed in the Full Analysis Set, which includes all subjects who received at least 1 dose of study drug.

Groups in this outcome

Dato DXd 6.0 mg/kg Q3W

Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
Dato DXd 6.0 mg/kg Q3W137

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dato DXd 6.0 mg/kg Q3W35.8Not reported27.844.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.8
        upper Limit
        44.4
        value
        35.8
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    units
    Participants
description
ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
    id
    OG000
    title
    Dato DXd 6.0 mg/kg Q3W
param Type
NUMBER
population Description
Outcome Measure was assessed in the Full Analysis Set, which includes all subjects who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.
title
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice