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NCT03521154 · OUTCOME

Number of Participants With Progression-free Survival (PFS) Events in Patients With EGFR Ex19del or L858R Mutation

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
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

Number of PFS events (PFS is time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on 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

Ex19Del positive

Analysis denominator · Participants

GroupSource count
Osimertinib74
Placebo43
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Osimertinib26Not reportedNot reportedNot reportedNot reported
Placebo39Not reportedNot reportedNot reportedNot reported
L858R positive

Analysis denominator · Participants

GroupSource count
Osimertinib68
Placebo30
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Osimertinib31Not reportedNot reportedNot reportedNot reported
Placebo24Not reportedNot reportedNot reportedNot reported
Missing

Analysis denominator · Participants

GroupSource count
Osimertinib1
Placebo0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Osimertinib0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.29
    estimate Comment
    A hazard ratio \< 1 favours osimertinib
    group Description
    PFS in Ex19Del positive patients
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.17
    statistical Method
    Cox proportional hazard model
  2. ci Lower Limit
    0.19
    ci Pct Value
    95
    ci Upper Limit
    0.56
    estimate Comment
    A hazard ratio \< 1 favours osimertinib
    group Description
    PFS in L858R positive patients
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.32
    statistical Method
    Cox proportional hazard model
Complete source fields
analyses
  1. ci Lower Limit
    0.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.29
    estimate Comment
    A hazard ratio \< 1 favours osimertinib
    group Description
    PFS in Ex19Del positive patients
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.17
    statistical Method
    Cox proportional hazard model
  2. ci Lower Limit
    0.19
    ci Pct Value
    95
    ci Upper Limit
    0.56
    estimate Comment
    A hazard ratio \< 1 favours osimertinib
    group Description
    PFS in L858R positive patients
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.32
    statistical Method
    Cox proportional hazard model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        39
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        43
      units
      Participants
    title
    Ex19Del positive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        24
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        30
      units
      Participants
    title
    L858R positive
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      143
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Number of PFS events (PFS is time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on BICR assessment according to RECIST v1.1)
groups
  1. description
    80mg once daily tablet
    id
    OG000
    title
    Osimertinib
  2. description
    Matching Placebo
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
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
Number of Participants With Progression-free Survival (PFS) Events in Patients With EGFR Ex19del or L858R Mutation
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice