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NCT04656652 · OUTCOME

Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) · Source last updated 2026-08-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months

What was measured

ORR is defined as the proportion of subjects who achieved a best overall response (BOR) of complete response (CR) or partial response (PR), as assessed by BICR and investigator per RECIST v1.1.

Groups in this outcome

DS-1062a 6.0 mg/kg

Participants were randomized to receive 6.0 mg/kg of DS-1062a.

Docetaxel 75 mg/m^2

Participants were randomized to receive 75 mg/m\^2 docetaxel.

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

Analysis denominator · Participants

GroupSource count
DS-1062a 6.0 mg/kg299
Docetaxel 75 mg/m^2305

Reported measurements

Assessed by Blinded Independent Central Review
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DS-1062a 6.0 mg/kg79Not reportedNot reportedNot reportedNot reported
Docetaxel 75 mg/m^239Not reportedNot reportedNot reportedNot reported
Assessed by Investigator
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DS-1062a 6.0 mg/kg74Not reportedNot reportedNot reportedNot reported
Docetaxel 75 mg/m^244Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        39
    title
    Assessed by Blinded Independent Central Review
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        44
    title
    Assessed by Investigator
denoms
  1. counts
    1. group Id
      OG000
      value
      299
    2. group Id
      OG001
      value
      305
    units
    Participants
description
ORR is defined as the proportion of subjects who achieved a best overall response (BOR) of complete response (CR) or partial response (PR), as assessed by BICR and investigator per RECIST v1.1.
groups
  1. description
    Participants were randomized to receive 6.0 mg/kg of DS-1062a.
    id
    OG000
    title
    DS-1062a 6.0 mg/kg
  2. description
    Participants were randomized to receive 75 mg/m\^2 docetaxel.
    id
    OG001
    title
    Docetaxel 75 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
title
Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice