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NCT01903993 · OUTCOME

Duration of Response (DOR)

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR" · Source last updated 2019-10-02

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 the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)

What was measured

DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.

Analysis population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Groups in this outcome

Docetaxel

Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.

Atezolizumab

Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.

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

Analysis denominator · Participants

GroupSource count
Docetaxel21
Atezolizumab21

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Docetaxel7.2Not reported5.612.5Not reported
Atezolizumab18.6Not reported11.6NAUpper limit of confidence interval (CI) was not achieved due to low number of participants with event.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.15
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.70
    group Description
    HR were estimated by a unstratified Cox regression model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    = 0.0028
    param Type
    Hazard Ratio (HR)
    param Value
    0.32
    statistical Method
    Log rank (unstratified)
Complete source fields
analyses
  1. ci Lower Limit
    0.15
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.70
    group Description
    HR were estimated by a unstratified Cox regression model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    = 0.0028
    param Type
    Hazard Ratio (HR)
    param Value
    0.32
    statistical Method
    Log rank (unstratified)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.6
        upper Limit
        12.5
        value
        7.2
      2. comment
        Upper limit of confidence interval (CI) was not achieved due to low number of participants with event.
        group Id
        OG001
        lower Limit
        11.6
        upper Limit
        NA
        value
        18.6
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      21
    units
    Participants
description
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
    id
    OG000
    title
    Docetaxel
  2. description
    Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
    id
    OG001
    title
    Atezolizumab
param Type
MEDIAN
population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice