Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04025879 · OUTCOME

Major Pathological Response (MPR) Rate

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer · Source last updated 2026-08-26

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 randomization up to approximately 44 months

What was measured

Major pathological response (MPR) rate is defined as the percentage of randomized participants with ≤10% residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).

Analysis population: All randomized participants

Groups in this outcome

Nivolumab + SOC Chemotherapy

Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)

Placebo + SOC Chemotherapy

Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).

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

Analysis denominator · Participants

GroupSource count
Nivolumab + SOC Chemotherapy229
Placebo + SOC Chemotherapy232

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + SOC Chemotherapy35.4Not reported29.241.9Not reported
Placebo + SOC Chemotherapy12.1Not reported8.217.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    15.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    30.6
    estimate Comment
    Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    DIFFERENCE OF MPR
    param Value
    23.2
  2. ci Lower Limit
    2.48
    ci Pct Value
    95
    ci Upper Limit
    6.49
    estimate Comment
    Strata adjusted odds ratio using Mantel-Haenszel method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    4.01
Complete source fields
analyses
  1. ci Lower Limit
    15.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    30.6
    estimate Comment
    Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    DIFFERENCE OF MPR
    param Value
    23.2
  2. ci Lower Limit
    2.48
    ci Pct Value
    95
    ci Upper Limit
    6.49
    estimate Comment
    Strata adjusted odds ratio using Mantel-Haenszel method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    4.01
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.2
        upper Limit
        41.9
        value
        35.4
      2. group Id
        OG001
        lower Limit
        8.2
        upper Limit
        17.0
        value
        12.1
denoms
  1. counts
    1. group Id
      OG000
      value
      229
    2. group Id
      OG001
      value
      232
    units
    Participants
description
Major pathological response (MPR) rate is defined as the percentage of randomized participants with ≤10% residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
    id
    OG000
    title
    Nivolumab + SOC Chemotherapy
  2. description
    Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
    id
    OG001
    title
    Placebo + SOC Chemotherapy
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization up to approximately 44 months
title
Major Pathological Response (MPR) Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice