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NCT02366143 · OUTCOME

OS in Arm A Versus Arm B 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 death (up approximately 53 months)

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 A (Atezolizumab+Paclitaxel+Carboplatin)

Participants received intravenous (IV) infusion of atezolizumab 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 during maintenance treatment phase until loss of clinical benefit.

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.

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+Paclitaxel+Carboplatin)350
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)359

Reported measurements

Teff High-WT Population

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)163
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)156
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)21.3Not reported17.626.3Not reported
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)25.8Not reported19.132.6Not reported
ITT-WT Population

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)350
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)359
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)19.0Not reported15.721.5Not reported
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)19.5Not reported17.022.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.683
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.188
    group Description
    Teff high-WT ITT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4599
    param Type
    Hazard Ratio (HR)
    param Value
    0.901
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.683
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.188
    group Description
    Teff high-WT ITT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4599
    param Type
    Hazard Ratio (HR)
    param Value
    0.901
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.6
        upper Limit
        26.3
        value
        21.3
      2. group Id
        OG001
        lower Limit
        19.1
        upper Limit
        32.6
        value
        25.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        163
      2. group Id
        OG001
        value
        156
      units
      Participants
    title
    Teff High-WT Population
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.7
        upper Limit
        21.5
        value
        19.0
      2. group Id
        OG001
        lower Limit
        17.0
        upper Limit
        22.2
        value
        19.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        350
      2. group Id
        OG001
        value
        359
      units
      Participants
    title
    ITT-WT Population
denoms
  1. counts
    1. group Id
      OG000
      value
      350
    2. group Id
      OG001
      value
      359
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received intravenous (IV) infusion of atezolizumab 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 during maintenance treatment phase until loss of clinical benefit.
    id
    OG000
    title
    Arm A (Atezolizumab+Paclitaxel+Carboplatin)
  2. 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
    OG001
    title
    Arm B (Atezolizumab+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 death (up approximately 53 months)
title
OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice