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NCT03521154 · OUTCOME

Central Nervous System (CNS) Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA) · Source last updated 2026-08-04

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
Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months

What was measured

Time from randomisation until the date of CNS disease progression or death (by any cause in the absence of CNS progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on CNS BICR assessment according to RECIST v1.1

Analysis population: Full analysis set

Groups in this outcome

Osimertinib

80mg once daily tablet

Placebo

Matching Placebo

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

Analysis denominator · Participants

GroupSource count
Osimertinib143
Placebo73

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
OsimertinibNANot reportedNANANA - Not calculated as insufficient number of events to enable the median and 95% confidence interval to be calculated
Placebo14.88Not reported7.36NANA - Not calculated as insufficient number of events to enable the upper limit of the 95% confidence interval to be calculated

Source statistical analyses

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

  1. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.32
    estimate Comment
    A hazard ratio \< 1 favours osimertinib
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.17
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.09
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.32
    estimate Comment
    A hazard ratio \< 1 favours osimertinib
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.17
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA - Not calculated as insufficient number of events to enable the median and 95% confidence interval to be calculated
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        NA - Not calculated as insufficient number of events to enable the upper limit of the 95% confidence interval to be calculated
        group Id
        OG001
        lower Limit
        7.36
        upper Limit
        NA
        value
        14.88
denoms
  1. counts
    1. group Id
      OG000
      value
      143
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Time from randomisation until the date of CNS disease progression or death (by any cause in the absence of CNS progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on CNS BICR assessment according to RECIST v1.1
dispersion Type
95% Confidence Interval
groups
  1. description
    80mg once daily tablet
    id
    OG000
    title
    Osimertinib
  2. description
    Matching Placebo
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Full analysis set
reporting Status
POSTED
time Frame
Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
title
Central Nervous System (CNS) Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice