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NCT02366143 · OUTCOME

PFS, as Determined by the Investigator 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 disease progression or death, whichever occurs first (up to approximately 29 months)

What was measured

PFS as Determined by the Investigator according to RECIST v1.1, 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)190
Arm C (Bevacizumab+Paclitaxel+Carboplatin)164

Reported measurements

TC2/3 or IC2/3 Subgroup

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)129
Arm C (Bevacizumab+Paclitaxel+Carboplatin)115
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)11.1Not reported8.313.0Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)6.8Not reported5.87.7Not reported
TC1/2/3 or IC1/2/3 Subgroup

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)190
Arm C (Bevacizumab+Paclitaxel+Carboplatin)164
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)11.0Not reported8.312.5Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)6.8Not reported5.87.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.352
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.647
    group Description
    TC2/3 or IC2/3 Subgroup
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.471
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.386
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.639
    group Description
    TC1/2/3 or IC1/2/3 Subgroup
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.486
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.352
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.647
    group Description
    TC2/3 or IC2/3 Subgroup
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.471
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.386
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.639
    group Description
    TC1/2/3 or IC1/2/3 Subgroup
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.486
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.3
        upper Limit
        13.0
        value
        11.1
      2. group Id
        OG001
        lower Limit
        5.8
        upper Limit
        7.7
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        115
      units
      Participants
    title
    TC2/3 or IC2/3 Subgroup
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.3
        upper Limit
        12.5
        value
        11.0
      2. group Id
        OG001
        lower Limit
        5.8
        upper Limit
        7.3
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      2. group Id
        OG001
        value
        164
      units
      Participants
    title
    TC1/2/3 or IC1/2/3 Subgroup
denoms
  1. counts
    1. group Id
      OG000
      value
      190
    2. group Id
      OG001
      value
      164
    units
    Participants
description
PFS as Determined by the Investigator according to RECIST v1.1, 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 disease progression or death, whichever occurs first (up to approximately 29 months)
title
PFS, as Determined by the Investigator 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