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NCT04025879 · OUTCOME

Pathologic Complete Response (pCR) 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

Pathologic complete response (pCR) rate is defined as the percentage of randomized participants with absence of 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 Chemotherapy25.3Not reported19.831.5Not reported
Placebo + SOC Chemotherapy4.7Not reported2.48.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    14.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    26.6
    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 PCR
    param Value
    20.5
  2. ci Lower Limit
    3.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.97
    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
    6.64
Complete source fields
analyses
  1. ci Lower Limit
    14.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    26.6
    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 PCR
    param Value
    20.5
  2. ci Lower Limit
    3.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.97
    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
    6.64
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.8
        upper Limit
        31.5
        value
        25.3
      2. group Id
        OG001
        lower Limit
        2.4
        upper Limit
        8.3
        value
        4.7
denoms
  1. counts
    1. group Id
      OG000
      value
      229
    2. group Id
      OG001
      value
      232
    units
    Participants
description
Pathologic complete response (pCR) rate is defined as the percentage of randomized participants with absence of 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
Pathologic Complete Response (pCR) Rate
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice