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NCT01673867 · OUTCOME

Overall Survival (OS) by PD-L1 Expression at Baseline

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC · Source last updated 2023-02-08

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 randomization to the date of death or last known date alive (up to approximately 110 months)

What was measured

Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.

Analysis population: All randomized participants who had a tumor biopsy assessed for PD-L1 expression

Groups in this outcome

Nivolumab

Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

Docetaxel

Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

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

Analysis denominator · Participants

GroupSource count
Nivolumab231
Docetaxel224

Reported measurements

Participants with baseline PD-L1 expression ≥ 5%

Analysis denominator · Participants

GroupSource count
Nivolumab94
Docetaxel86
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab19.91Not reported15.0826.12Not reported
Docetaxel8.11Not reported6.4710.05Not reported
Participants with baseline PD-L1 expression < 5%

Analysis denominator · Participants

GroupSource count
Nivolumab137
Docetaxel138
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab9.86Not reported6.9312.81Not reported
Docetaxel10.28Not reported8.5411.96Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.08
        upper Limit
        26.12
        value
        19.91
      2. group Id
        OG001
        lower Limit
        6.47
        upper Limit
        10.05
        value
        8.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        86
      units
      Participants
    title
    Participants with baseline PD-L1 expression ≥ 5%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.93
        upper Limit
        12.81
        value
        9.86
      2. group Id
        OG001
        lower Limit
        8.54
        upper Limit
        11.96
        value
        10.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        137
      2. group Id
        OG001
        value
        138
      units
      Participants
    title
    Participants with baseline PD-L1 expression < 5%
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    2. group Id
      OG001
      value
      224
    units
    Participants
description
Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    id
    OG000
    title
    Nivolumab
  2. description
    Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    id
    OG001
    title
    Docetaxel
param Type
MEDIAN
population Description
All randomized participants who had a tumor biopsy assessed for PD-L1 expression
reporting Status
POSTED
time Frame
From randomization to the date of death or last known date alive (up to approximately 110 months)
title
Overall Survival (OS) by PD-L1 Expression at Baseline
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice