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NCT02504372 · OUTCOME

DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%

Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091) · Source last updated 2026-03-17

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
Up to approximately 84 months

What was measured

DFS in PDL-1 strong positive participants with TPS ≥50% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Analysis population: All randomized PDL-1 strong positive participants with TPS ≥50%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Groups in this outcome

Pembrolizumab

Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.

Placebo

Participants received placebo, IV, every 3 weeks, for one 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
Pembrolizumab168
Placebo165

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab67.0Not reported47.8NANA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.
Placebo47.6Not reported36.4NANA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.

Source statistical analyses

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

  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.16
    estimate Comment
    HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.13499
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Comment
    One-sided p-value was based on the permutation test with multivariate Cox regression model.
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.16
    estimate Comment
    HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.13499
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Comment
    One-sided p-value was based on the permutation test with multivariate Cox regression model.
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. comment
        NA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        47.8
        upper Limit
        NA
        value
        67.0
      2. comment
        NA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        36.4
        upper Limit
        NA
        value
        47.6
denoms
  1. counts
    1. group Id
      OG000
      value
      168
    2. group Id
      OG001
      value
      165
    units
    Participants
description
DFS in PDL-1 strong positive participants with TPS ≥50% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
    id
    OG000
    title
    Pembrolizumab
  2. description
    Participants received placebo, IV, every 3 weeks, for one year.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
All randomized PDL-1 strong positive participants with TPS ≥50%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
reporting Status
POSTED
time Frame
Up to approximately 84 months
title
DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice