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NCT02125461 · OUTCOME

Overall Survival

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer · Source last updated 2023-10-10

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 baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.

What was measured

OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.

Analysis population: FAS included all randomized patients, analyzed on an ITT basis.

Groups in this outcome

Durvalumab (MEDI4736)

Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.

Placebo

Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.

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

Analysis denominator · Participants

GroupSource count
Durvalumab (MEDI4736)476
Placebo237

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durvalumab (MEDI4736)NANot reported34.7NAThe median and upper limit of 95% confidence interval (CI) could not be calculated as they were not reached.
Placebo28.7Not reported22.9NAUpper limit of 95% CI could not be calculated as it was not reached.

Source statistical analyses

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

  1. ci Lower Limit
    0.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    group Description
    Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00251
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    group Description
    Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00251
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median and upper limit of 95% confidence interval (CI) could not be calculated as they were not reached.
        group Id
        OG000
        lower Limit
        34.7
        upper Limit
        NA
        value
        NA
      2. comment
        Upper limit of 95% CI could not be calculated as it was not reached.
        group Id
        OG001
        lower Limit
        22.9
        upper Limit
        NA
        value
        28.7
denoms
  1. counts
    1. group Id
      OG000
      value
      476
    2. group Id
      OG001
      value
      237
    units
    Participants
description
OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
    id
    OG000
    title
    Durvalumab (MEDI4736)
  2. description
    Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
FAS included all randomized patients, analyzed on an ITT basis.
reporting Status
POSTED
time Frame
From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
title
Overall Survival
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice