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NCT01903993 · OUTCOME

Overall Survival (OS)

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

Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.

Analysis population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.

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
Docetaxel143
Atezolizumab144

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Docetaxel9.7Not reported8.612.0Not reported
Atezolizumab12.6Not reported9.716.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    group Description
    Hazard ratios (HR) were estimated by a Cox regression model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    = 0.0106
    param Type
    Hazard Ratio (HR)
    param Value
    0.69
    statistical Method
    Log rank (Stratified)
Complete source fields
analyses
  1. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    group Description
    Hazard ratios (HR) were estimated by a Cox regression model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    = 0.0106
    param Type
    Hazard Ratio (HR)
    param Value
    0.69
    statistical Method
    Log rank (Stratified)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.6
        upper Limit
        12.0
        value
        9.7
      2. group Id
        OG001
        lower Limit
        9.7
        upper Limit
        16.0
        value
        12.6
denoms
  1. counts
    1. group Id
      OG000
      value
      143
    2. group Id
      OG001
      value
      144
    units
    Participants
description
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
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. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
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
Overall Survival (OS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice