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NCT03215706 · OUTCOME

Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC · Source last updated 2025-12-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)

What was measured

ORR was defined as the proportion of randomized participants with a best overall response (BOR) of confirmed complete or partial response per BICR using RECIST v1.1. BOR was assessed from randomization until documented progression, start of palliative local or subsequent anti-cancer therapy-whichever came first. If none occurred, all response data contributed to BOR. For those treated beyond progression, BOR was based on responses before initial RECIST-defined progression. PD-L1 expression was measured via Dako PD-L1 IHC 28-8 pharmDx test as the percentage of tumor cells with membrane staining among ≥100 evaluable cells. Expression was categorized as ≥1%, \<1%, not quantifiable, ≥50%, or 1-49%.

Analysis population: All Randomized Participants, Global Population

Groups in this outcome

Treatment A

Nivolumab + Ipilimumab + Chemotherapy

Treatment B

Chemotherapy only

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

Analysis denominator · Participants

GroupSource count
Treatment A361
Treatment B358

Reported measurements

BASELINE PD-L1 EXPRESSION ≥1%

Analysis denominator · Participants

GroupSource count
Treatment A204
Treatment B204
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A42.6Not reported35.849.7Not reported
Treatment B27.5Not reported21.534.1Not reported
BASELINE PD-L1 EXPRESSION < 1%

Analysis denominator · Participants

GroupSource count
Treatment A135
Treatment B129
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A31.1Not reported23.439.6Not reported
Treatment B20.2Not reported13.628.1Not reported
Non-Quantifiable PD-L1 Expression

Analysis denominator · Participants

GroupSource count
Treatment A22
Treatment B25
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A36.4Not reported17.259.3Not reported
Treatment B32.0Not reported14.953.5Not reported
BASELINE PD-L1 EXPRESSION 1 - 49%

Analysis denominator · Participants

GroupSource count
Treatment A128
Treatment B106
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A38.3Not reported29.847.3Not reported
Treatment B23.6Not reported15.932.8Not reported
BASELINE PD-L1 EXPRESSION >= 50%

Analysis denominator · Participants

GroupSource count
Treatment A76
Treatment B98
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A50.0Not reported38.361.7Not reported
Treatment B31.6Not reported22.641.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.8
        upper Limit
        49.7
        value
        42.6
      2. group Id
        OG001
        lower Limit
        21.5
        upper Limit
        34.1
        value
        27.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        204
      2. group Id
        OG001
        value
        204
      units
      Participants
    title
    BASELINE PD-L1 EXPRESSION ≥1%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.4
        upper Limit
        39.6
        value
        31.1
      2. group Id
        OG001
        lower Limit
        13.6
        upper Limit
        28.1
        value
        20.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        135
      2. group Id
        OG001
        value
        129
      units
      Participants
    title
    BASELINE PD-L1 EXPRESSION < 1%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.2
        upper Limit
        59.3
        value
        36.4
      2. group Id
        OG001
        lower Limit
        14.9
        upper Limit
        53.5
        value
        32.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    Non-Quantifiable PD-L1 Expression
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.8
        upper Limit
        47.3
        value
        38.3
      2. group Id
        OG001
        lower Limit
        15.9
        upper Limit
        32.8
        value
        23.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        128
      2. group Id
        OG001
        value
        106
      units
      Participants
    title
    BASELINE PD-L1 EXPRESSION 1 - 49%
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.3
        upper Limit
        61.7
        value
        50.0
      2. group Id
        OG001
        lower Limit
        22.6
        upper Limit
        41.8
        value
        31.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        98
      units
      Participants
    title
    BASELINE PD-L1 EXPRESSION >= 50%
denoms
  1. counts
    1. group Id
      OG000
      value
      361
    2. group Id
      OG001
      value
      358
    units
    Participants
description
ORR was defined as the proportion of randomized participants with a best overall response (BOR) of confirmed complete or partial response per BICR using RECIST v1.1. BOR was assessed from randomization until documented progression, start of palliative local or subsequent anti-cancer therapy-whichever came first. If none occurred, all response data contributed to BOR. For those treated beyond progression, BOR was based on responses before initial RECIST-defined progression. PD-L1 expression was measured via Dako PD-L1 IHC 28-8 pharmDx test as the percentage of tumor cells with membrane staining among ≥100 evaluable cells. Expression was categorized as ≥1%, \<1%, not quantifiable, ≥50%, or 1-49%.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab + Ipilimumab + Chemotherapy
    id
    OG000
    title
    Treatment A
  2. description
    Chemotherapy only
    id
    OG001
    title
    Treatment B
param Type
NUMBER
population Description
All Randomized Participants, Global Population
reporting Status
POSTED
time Frame
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
title
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice