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NCT01642004 · OUTCOME

Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017) · Source last updated 2022-12-28

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
From the date of randomization to the date of death from any cause, up to approximately 103 months

What was measured

OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

Docetaxel

Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Nivolumab135
Docetaxel137

Reported measurements

PD-L1 expression >= 5%

Analysis denominator · Participants

GroupSource count
Nivolumab42
Docetaxel39
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab9.95Not reported5.8216.69Not reported
Docetaxel6.37Not reported4.509.03Not reported
PD-L1 expression < 5%

Analysis denominator · Participants

GroupSource count
Nivolumab75
Docetaxel69
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab8.54Not reported5.4912.62Not reported
Docetaxel6.14Not reported5.138.28Not reported
PD-L1 not quantifiable at baseline

Analysis denominator · Participants

GroupSource count
Nivolumab18
Docetaxel29
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab9.41Not reported7.1025.20Not reported
Docetaxel5.06Not reported3.026.11Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.82
        upper Limit
        16.69
        value
        9.95
      2. group Id
        OG001
        lower Limit
        4.50
        upper Limit
        9.03
        value
        6.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    PD-L1 expression >= 5%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.49
        upper Limit
        12.62
        value
        8.54
      2. group Id
        OG001
        lower Limit
        5.13
        upper Limit
        8.28
        value
        6.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    PD-L1 expression < 5%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.10
        upper Limit
        25.20
        value
        9.41
      2. group Id
        OG001
        lower Limit
        3.02
        upper Limit
        6.11
        value
        5.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        29
      units
      Participants
    title
    PD-L1 not quantifiable at baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      135
    2. group Id
      OG001
      value
      137
    units
    Participants
description
OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
    id
    OG000
    title
    Nivolumab
  2. description
    Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    id
    OG001
    title
    Docetaxel
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From the date of randomization to the date of death from any cause, up to approximately 103 months
title
Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice