NCT03521154 · OUTCOME

Second Progression-free Survival (PFS2)

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. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months

What was measured

Time from randomisation to the earliest progression event following first objective disease progression, subsequent to the first subsequent therapy, or death.

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

Group	Source count
Osimertinib	143
Placebo	73

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Osimertinib	48.20	Not reported	44.42	NA	NA - Not calculated as insufficient number of events to enable the upper limit of 95% confidence interval to be calculated
Placebo	47.38	Not reported	28.22	NA	NA - Not calculated as insufficient number of events to enable the upper limit of 95% confidence interval to be calculated

Source statistical analyses

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

ci Lower Limit
0.35
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.08
estimate Comment
A hazard ratio \< 1 favours osimertinib
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.088
param Type
Hazard Ratio (HR)
param Value
0.62
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.35
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.08
estimate Comment
A hazard ratio \< 1 favours osimertinib
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.088
param Type
Hazard Ratio (HR)
param Value
0.62
statistical Method
Log Rank

classes

categories
measurements
comment
NA - Not calculated as insufficient number of events to enable the upper limit of 95% confidence interval to be calculated
group Id
OG000
lower Limit
44.42
upper Limit
NA
value
48.20
comment
NA - Not calculated as insufficient number of events to enable the upper limit of 95% confidence interval to be calculated
group Id
OG001
lower Limit
28.22
upper Limit
NA
value
47.38

denoms

counts
group Id
OG000
value
143
group Id
OG001
value
73
units
Participants

description

Time from randomisation to the earliest progression event following first objective disease progression, subsequent to the first subsequent therapy, or death.

dispersion Type

95% Confidence Interval

groups

description
80mg once daily tablet
id
OG000
title
Osimertinib
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. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months

title

Second Progression-free Survival (PFS2)

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice