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NCT02008227 · OUTCOME

Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy · Source last updated 2019-12-20

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
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

What was measured

Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.

Analysis population: The PP-ITT analysis set.

Groups in this outcome

Docetaxel

Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

Atezolizumab

Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Docetaxel425
Atezolizumab425

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Docetaxel13.4Not reported10.3217.02Not reported
Atezolizumab13.6Not reported10.5317.28Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.32
        upper Limit
        17.02
        value
        13.4
      2. group Id
        OG001
        lower Limit
        10.53
        upper Limit
        17.28
        value
        13.6
denoms
  1. counts
    1. group Id
      OG000
      value
      425
    2. group Id
      OG001
      value
      425
    units
    Participants
description
Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Docetaxel 75 milligrams per square meter (mg/m\^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
    id
    OG000
    title
    Docetaxel
  2. description
    Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
    id
    OG001
    title
    Atezolizumab
param Type
NUMBER
population Description
The PP-ITT analysis set.
reporting Status
POSTED
time Frame
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
title
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice