Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02367781 · OUTCOME

OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-08-09

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
Up to approximately 35 months after first patient enrolled

What was measured

OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.

Analysis population: PD-L1 Expression Population and PD-L1 Expression WT Population

Groups in this outcome

Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)

Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 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 (Nab-Paclitaxel+Carboplatin)

Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.

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+Nab-Paclitaxel+Carboplatin)230
Arm B (Nab-Paclitaxel+Carboplatin)111

Reported measurements

TC1/2/3 or IC1/2/3 ITT Population

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)230
Arm B (Nab-Paclitaxel+Carboplatin)111
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)21.2Not reported17.328.2Not reported
Arm B (Nab-Paclitaxel+Carboplatin)16.9Not reported12.522.0Not reported
TC1/2/3 or IC1/2/3 WT ITT Population

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)216
Arm B (Nab-Paclitaxel+Carboplatin)107
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)21.2Not reported18.128.2Not reported
Arm B (Nab-Paclitaxel+Carboplatin)16.9Not reported12.522.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.545
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.039
    group Description
    TC1/2/3 or IC1/2/3 ITT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0830
    param Type
    Hazard Ratio (HR)
    param Value
    0.752
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.536
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.038
    group Description
    TC1/2/3 or IC1/2/3 WT ITT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0813
    param Type
    Hazard Ratio (HR)
    param Value
    0.746
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.545
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.039
    group Description
    TC1/2/3 or IC1/2/3 ITT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0830
    param Type
    Hazard Ratio (HR)
    param Value
    0.752
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.536
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.038
    group Description
    TC1/2/3 or IC1/2/3 WT ITT Population
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0813
    param Type
    Hazard Ratio (HR)
    param Value
    0.746
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.3
        upper Limit
        28.2
        value
        21.2
      2. group Id
        OG001
        lower Limit
        12.5
        upper Limit
        22.0
        value
        16.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        230
      2. group Id
        OG001
        value
        111
      units
      Participants
    title
    TC1/2/3 or IC1/2/3 ITT Population
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.1
        upper Limit
        28.2
        value
        21.2
      2. group Id
        OG001
        lower Limit
        12.5
        upper Limit
        22.0
        value
        16.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        216
      2. group Id
        OG001
        value
        107
      units
      Participants
    title
    TC1/2/3 or IC1/2/3 WT ITT Population
denoms
  1. counts
    1. group Id
      OG000
      value
      230
    2. group Id
      OG001
      value
      111
    units
    Participants
description
OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 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+Nab-Paclitaxel+Carboplatin)
  2. description
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
    id
    OG001
    title
    Arm B (Nab-Paclitaxel+Carboplatin)
param Type
MEDIAN
population Description
PD-L1 Expression Population and PD-L1 Expression WT Population
reporting Status
POSTED
time Frame
Up to approximately 35 months after first patient enrolled
title
OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice