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NCT03215706 · OUTCOME

OS by Tumor Mutational Burden

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization to date of death (assessed up to October 2024, approximately 72 months)

What was measured

OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.

Analysis population: All Randomized Participants, Global Population with tumor mutational burden measurements

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 A355
Treatment B356

Reported measurements

≥ 10 Mutations/MB

Analysis denominator · Participants

GroupSource count
Treatment A101
Treatment B82
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A15.05Not reported12.4520.76Not reported
Treatment B10.76Not reported7.8515.41Not reported
< 10 Mutations/MB

Analysis denominator · Participants

GroupSource count
Treatment A136
Treatment B137
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A16.51Not reported11.9919.98Not reported
Treatment B12.55Not reported10.3814.92Not reported
Overall

Analysis denominator · Participants

GroupSource count
Treatment A237
Treatment B219
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A15.57Not reported13.3419.38Not reported
Treatment B12.06Not reported10.3514.06Not reported
Not Evaluable

Analysis denominator · Participants

GroupSource count
Treatment A118
Treatment B137
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A17.10Not reported13.4725.49Not reported
Treatment B9.46Not reported8.1511.79Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.45
        upper Limit
        20.76
        value
        15.05
      2. group Id
        OG001
        lower Limit
        7.85
        upper Limit
        15.41
        value
        10.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      2. group Id
        OG001
        value
        82
      units
      Participants
    title
    ≥ 10 Mutations/MB
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.99
        upper Limit
        19.98
        value
        16.51
      2. group Id
        OG001
        lower Limit
        10.38
        upper Limit
        14.92
        value
        12.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        136
      2. group Id
        OG001
        value
        137
      units
      Participants
    title
    < 10 Mutations/MB
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.34
        upper Limit
        19.38
        value
        15.57
      2. group Id
        OG001
        lower Limit
        10.35
        upper Limit
        14.06
        value
        12.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        237
      2. group Id
        OG001
        value
        219
      units
      Participants
    title
    Overall
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.47
        upper Limit
        25.49
        value
        17.10
      2. group Id
        OG001
        lower Limit
        8.15
        upper Limit
        11.79
        value
        9.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      2. group Id
        OG001
        value
        137
      units
      Participants
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      355
    2. group Id
      OG001
      value
      356
    units
    Participants
description
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
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
MEDIAN
population Description
All Randomized Participants, Global Population with tumor mutational burden measurements
reporting Status
POSTED
time Frame
From date of randomization to date of death (assessed up to October 2024, approximately 72 months)
title
OS by Tumor Mutational Burden
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice