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NCT02367781 · OUTCOME

Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 41 months after first patient enrolled, years 1 and 2 reported

What was measured

The OS rate at the 1- and 2-year landmark time points after randomization.

Analysis population: The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment.

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)483
Arm B (Nab-Paclitaxel+Carboplatin)240

Reported measurements

Event Free Rate (%) at Year 1 ITT WT

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)456
Arm B (Nab-Paclitaxel+Carboplatin)229
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)62.02Not reported57.5366.51Not reported
Arm B (Nab-Paclitaxel+Carboplatin)54.56Not reported48.0461.08Not reported
Event Free Rate (%) at Year 2 ITT WT

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)456
Arm B (Nab-Paclitaxel+Carboplatin)229
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)40.43Not reported35.6445.22Not reported
Arm B (Nab-Paclitaxel+Carboplatin)32.36Not reported25.8038.92Not reported
Event Free Rate (%) at Year 1 ITT

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)483
Arm B (Nab-Paclitaxel+Carboplatin)240
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)61.65Not reported57.2966.02Not reported
Arm B (Nab-Paclitaxel+Carboplatin)54.47Not reported48.0960.84Not reported
Event Free Rate (%) at Year 2 ITT

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)483
Arm B (Nab-Paclitaxel+Carboplatin)240
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)39.73Not reported35.1044.37Not reported
Arm B (Nab-Paclitaxel+Carboplatin)32.21Not reported25.7938.63Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    15.37
    group Description
    Event Free Rate (%) at Year 1 ITT WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0647
    param Type
    Difference in Event Free Rate
    param Value
    7.46
    statistical Method
    Z-test
  2. ci Lower Limit
    -0.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.19
    group Description
    Event Free Rate (%) at Year 2 ITT WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0516
    param Type
    Difference in Event Free Rate
    param Value
    8.07
    statistical Method
    Z-test
  3. ci Lower Limit
    -0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    14.91
    group Description
    Event Free Rate (%) at Year 1 ITT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0683
    param Type
    Difference in Event Free Rate
    param Value
    7.19
    statistical Method
    Z-test
  4. ci Lower Limit
    -0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    15.44
    group Description
    Event Free Rate (%) at Year 2 ITT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0625
    param Type
    Difference in Event Free Rate
    param Value
    7.53
    statistical Method
    Z-test
Complete source fields
analyses
  1. ci Lower Limit
    -0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    15.37
    group Description
    Event Free Rate (%) at Year 1 ITT WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0647
    param Type
    Difference in Event Free Rate
    param Value
    7.46
    statistical Method
    Z-test
  2. ci Lower Limit
    -0.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.19
    group Description
    Event Free Rate (%) at Year 2 ITT WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0516
    param Type
    Difference in Event Free Rate
    param Value
    8.07
    statistical Method
    Z-test
  3. ci Lower Limit
    -0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    14.91
    group Description
    Event Free Rate (%) at Year 1 ITT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0683
    param Type
    Difference in Event Free Rate
    param Value
    7.19
    statistical Method
    Z-test
  4. ci Lower Limit
    -0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    15.44
    group Description
    Event Free Rate (%) at Year 2 ITT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0625
    param Type
    Difference in Event Free Rate
    param Value
    7.53
    statistical Method
    Z-test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.53
        upper Limit
        66.51
        value
        62.02
      2. group Id
        OG001
        lower Limit
        48.04
        upper Limit
        61.08
        value
        54.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        456
      2. group Id
        OG001
        value
        229
      units
      Participants
    title
    Event Free Rate (%) at Year 1 ITT WT
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.64
        upper Limit
        45.22
        value
        40.43
      2. group Id
        OG001
        lower Limit
        25.80
        upper Limit
        38.92
        value
        32.36
    denoms
    1. counts
      1. group Id
        OG000
        value
        456
      2. group Id
        OG001
        value
        229
      units
      Participants
    title
    Event Free Rate (%) at Year 2 ITT WT
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.29
        upper Limit
        66.02
        value
        61.65
      2. group Id
        OG001
        lower Limit
        48.09
        upper Limit
        60.84
        value
        54.47
    denoms
    1. counts
      1. group Id
        OG000
        value
        483
      2. group Id
        OG001
        value
        240
      units
      Participants
    title
    Event Free Rate (%) at Year 1 ITT
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.10
        upper Limit
        44.37
        value
        39.73
      2. group Id
        OG001
        lower Limit
        25.79
        upper Limit
        38.63
        value
        32.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        483
      2. group Id
        OG001
        value
        240
      units
      Participants
    title
    Event Free Rate (%) at Year 2 ITT
denoms
  1. counts
    1. group Id
      OG000
      value
      483
    2. group Id
      OG001
      value
      240
    units
    Participants
description
The OS rate at the 1- and 2-year landmark time points after randomization.
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
NUMBER
population Description
The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment.
reporting Status
POSTED
time Frame
Up to 41 months after first patient enrolled, years 1 and 2 reported
title
Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice