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NCT02366143 · OUTCOME

PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-09-23

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
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

What was measured

PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.

Analysis population: Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Groups in this outcome

Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)

Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Arm C (Bevacizumab+Paclitaxel+Carboplatin)

Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

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 B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)356
Arm C (Bevacizumab+Paclitaxel+Carboplatin)336

Reported measurements

Teff-high WT Population

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)155
Arm C (Bevacizumab+Paclitaxel+Carboplatin)129
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)10.7Not reported8.413.0Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)7.0Not reported6.18.1Not reported
ITT-WT Population

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)356
Arm C (Bevacizumab+Paclitaxel+Carboplatin)336
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)8.5Not reported7.79.7Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)7.0Not reported6.38.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    group Description
    ITT-WT population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.71
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.418
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.760
    group Description
    Teff-high WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.564
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    group Description
    ITT-WT population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.71
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.418
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.760
    group Description
    Teff-high WT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.564
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.4
        upper Limit
        13.0
        value
        10.7
      2. group Id
        OG001
        lower Limit
        6.1
        upper Limit
        8.1
        value
        7.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        155
      2. group Id
        OG001
        value
        129
      units
      Participants
    title
    Teff-high WT Population
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.7
        upper Limit
        9.7
        value
        8.5
      2. group Id
        OG001
        lower Limit
        6.3
        upper Limit
        8.0
        value
        7.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        356
      2. group Id
        OG001
        value
        336
      units
      Participants
    title
    ITT-WT Population
denoms
  1. counts
    1. group Id
      OG000
      value
      356
    2. group Id
      OG001
      value
      336
    units
    Participants
description
PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
    id
    OG000
    title
    Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
  2. description
    Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
    id
    OG001
    title
    Arm C (Bevacizumab+Paclitaxel+Carboplatin)
param Type
MEDIAN
population Description
Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.
reporting Status
POSTED
time Frame
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
title
PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice