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NCT02367781 · OUTCOME

Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-08-09

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
Up to approximately 35 months after first subject enrolled

What was measured

Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.

Analysis population: The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.

Groups in this outcome

Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)

Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Arm B (Nab-Paclitaxel+Carboplatin)

Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.

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

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)451
Arm B (Nab-Paclitaxel+Carboplatin)228

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)2.2Not reported1.83.1Not reported
Arm B (Nab-Paclitaxel+Carboplatin)1.9Not reported1.52.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.711
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.123
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3342
    param Type
    Hazard Ratio (HR)
    param Value
    0.893
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.711
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.123
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3342
    param Type
    Hazard Ratio (HR)
    param Value
    0.893
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        3.1
        value
        2.2
      2. group Id
        OG001
        lower Limit
        1.5
        upper Limit
        2.4
        value
        1.9
denoms
  1. counts
    1. group Id
      OG000
      value
      451
    2. group Id
      OG001
      value
      228
    units
    Participants
description
Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
    id
    OG000
    title
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
  2. description
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
    id
    OG001
    title
    Arm B (Nab-Paclitaxel+Carboplatin)
param Type
MEDIAN
population Description
The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.
reporting Status
POSTED
time Frame
Up to approximately 35 months after first subject enrolled
title
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice