NCT02511106 · OUTCOME

Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy. · Source last updated 2026-03-30

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 5 years after the first patient is randomized (maximum follow up of 70 months)

What was measured

Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).

Analysis population: Full Analysis Set (FAS) stage IB-IIIA patients

Groups in this outcome

AZD9291 80mg Tablet

Taken once daily

Placebo Tablet

Taken once daily

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
AZD9291 80mg Tablet	339
Placebo Tablet	343

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	65.8	Not reported	61.7	NA	Insufficient DFS events to estimate upper 95% confidence interval (Kaplan Meier analysis)
Placebo Tablet	28.1	Not reported	22.1	35.0	Not reported

Source statistical analyses

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

ci Lower Limit
0.21
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.34
estimate Comment
A hazard ratio \<1 favours AZD9291.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.27
statistical Comment
Determined using a log rank test stratified by stage, race and mutation type.
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.21
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.34
estimate Comment
A hazard ratio \<1 favours AZD9291.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.27
statistical Comment
Determined using a log rank test stratified by stage, race and mutation type.
statistical Method
Log Rank

classes

categories
measurements
comment
Insufficient DFS events to estimate upper 95% confidence interval (Kaplan Meier analysis)
group Id
OG000
lower Limit
61.7
upper Limit
NA
value
65.8
group Id
OG001
lower Limit
22.1
upper Limit
35.0
value
28.1

denoms

counts
group Id
OG000
value
339
group Id
OG001
value
343
units
Participants

description

Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).

dispersion Type

95% Confidence Interval

groups

description
Taken once daily
id
OG000
title
AZD9291 80mg Tablet
description
Taken once daily
id
OG001
title
Placebo Tablet

param Type

MEDIAN

population Description

Full Analysis Set (FAS) stage IB-IIIA patients

reporting Status

POSTED

time Frame

Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)

title

Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).

type

PRIMARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice