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NCT02366143 · OUTCOME

PFS, as Determined by the Investigator 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 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 A versus B in the Teff high-WT population and 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 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)348
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)356

Reported measurements

Teff-high WT

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)161
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)155
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)6.3Not reported5.67.8Not reported
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)11.3Not reported9.113.0Not reported
ITT-WT

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)348
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)356
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)6.3Not reported5.67.0Not reported
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)8.3Not reported7.79.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.6
        upper Limit
        7.8
        value
        6.3
      2. group Id
        OG001
        lower Limit
        9.1
        upper Limit
        13.0
        value
        11.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        161
      2. group Id
        OG001
        value
        155
      units
      Participants
    title
    Teff-high WT
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.6
        upper Limit
        7.0
        value
        6.3
      2. group Id
        OG001
        lower Limit
        7.7
        upper Limit
        9.8
        value
        8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        348
      2. group Id
        OG001
        value
        356
      units
      Participants
    title
    ITT-WT
denoms
  1. counts
    1. group Id
      OG000
      value
      348
    2. group Id
      OG001
      value
      356
    units
    Participants
description
PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.
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 disease progression or death, whichever occurs first (up to approximately 29 months)
title
PFS, as Determined by the Investigator in Arm A Versus Arm B 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