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NCT02366143 · OUTCOME

OS in Arm B Versus Arm C by PD-L1 Subgroup

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 death (up to approximately 34 months)

What was measured

OS in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

Analysis population: The PD-L1-selected WT populations are defined as the PD-L1-selected populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with a sensitizing 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)192
Arm C (Bevacizumab+Paclitaxel+Carboplatin)165

Reported measurements

TC 2/3 or IC2/3 Population

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)129
Arm C (Bevacizumab+Paclitaxel+Carboplatin)116
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)22.2Not reported17.026.1Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)16.7Not reported10.524.2Not reported
TC1/2/3 or IC1/2/3 Population

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)192
Arm C (Bevacizumab+Paclitaxel+Carboplatin)165
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)22.5Not reported18.226.1Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)16.4Not reported11.222.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.580
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.169
    group Description
    TC2/3 or IC2/3, WT ITT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2765
    param Type
    Hazard Ratio (HR)
    param Value
    0.824
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.575
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.035
    group Description
    TC1/2/3 or IC1/2/3, WT ITT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0829
    param Type
    Hazard Ratio (HR)
    param Value
    0.771
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.580
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.169
    group Description
    TC2/3 or IC2/3, WT ITT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2765
    param Type
    Hazard Ratio (HR)
    param Value
    0.824
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.575
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.035
    group Description
    TC1/2/3 or IC1/2/3, WT ITT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0829
    param Type
    Hazard Ratio (HR)
    param Value
    0.771
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.0
        upper Limit
        26.1
        value
        22.2
      2. group Id
        OG001
        lower Limit
        10.5
        upper Limit
        24.2
        value
        16.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        116
      units
      Participants
    title
    TC 2/3 or IC2/3 Population
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.2
        upper Limit
        26.1
        value
        22.5
      2. group Id
        OG001
        lower Limit
        11.2
        upper Limit
        22.9
        value
        16.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        192
      2. group Id
        OG001
        value
        165
      units
      Participants
    title
    TC1/2/3 or IC1/2/3 Population
denoms
  1. counts
    1. group Id
      OG000
      value
      192
    2. group Id
      OG001
      value
      165
    units
    Participants
description
OS in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (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
The PD-L1-selected WT populations are defined as the PD-L1-selected populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with a sensitizing EGFR mutation or ALK translocation.
reporting Status
POSTED
time Frame
Baseline until death (up to approximately 34 months)
title
OS in Arm B Versus Arm C by PD-L1 Subgroup
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice