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NCT04025879 · OUTCOME

Event-Free Survival (EFS) by BICR

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)

What was measured

The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + SOC ChemotherapyNANot reported28.94Not reportedInsufficient number of participants with events
Placebo + SOC Chemotherapy18.43Not reported13.6328.06Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    estimate Comment
    Stratified by randomization stratification factors: PD-L1 Status (\>=1% vs \<1%/not evaluable/indeterminate), disease stage (II vs III), histology (squamous vs non-squamous).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00025
    param Type
    Cox Proportional Hazard
    param Value
    0.58
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    estimate Comment
    Stratified by randomization stratification factors: PD-L1 Status (\>=1% vs \<1%/not evaluable/indeterminate), disease stage (II vs III), histology (squamous vs non-squamous).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00025
    param Type
    Cox Proportional Hazard
    param Value
    0.58
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events
        group Id
        OG000
        lower Limit
        28.94
        value
        NA
      2. group Id
        OG001
        lower Limit
        13.63
        upper Limit
        28.06
        value
        18.43
denoms
  1. counts
    1. group Id
      OG000
      value
      229
    2. group Id
      OG001
      value
      232
    units
    Participants
description
The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death
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
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
title
Event-Free Survival (EFS) by BICR
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice