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NCT03215706 · OUTCOME

Objective Response Rate (ORR) by BICR

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 number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.

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

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A38.0Not reported32.943.2Not reported
Treatment B25.1Not reported20.730.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    6.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A over Treatment B
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    12.7
    statistical Method
    Mantel Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    6.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A over Treatment B
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    12.7
    statistical Method
    Mantel Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.9
        upper Limit
        43.2
        value
        38.0
      2. group Id
        OG001
        lower Limit
        20.7
        upper Limit
        30.0
        value
        25.1
denoms
  1. counts
    1. group Id
      OG000
      value
      361
    2. group Id
      OG001
      value
      358
    units
    Participants
description
ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
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
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice