NCT02737501 · OUTCOME

Duration of Response (DOR)

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants · Source last updated 2021-08-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: months
Interval / dispersion: Full Range
Time frame: Baseline up to end of study (Up to 56 months)

What was measured

Duration of response as assessed by BIRC, is defined as the time interval from the date that the criteria are first met for CR/PR (whichever is first recorded) until the first date that progressive disease (PD) is objectively documented. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30 % decrease in the SLD of target lesions, taking as reference the baseline sum diameters. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and for non-target lesions, unequivocal progression of existing non-target lesions.

Analysis population: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Only responders were reported for this outcome measure.

Groups in this outcome

Randomized Phase: Brigatinib 90 mg QD/180 QD

Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).

Randomized Phase: Crizotinib 250 mg BID

Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).

Crossover Phase: Brigatinib 90 mg QD/180 mg QD

Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).

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
Randomized Phase: Brigatinib 90 mg QD/180 QD	102
Randomized Phase: Crizotinib 250 mg BID	86
Crossover Phase: Brigatinib 90 mg QD/180 mg QD	37

Reported measurements

Source class 1

Values in months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Randomized Phase: Brigatinib 90 mg QD/180 QD	33.150	Not reported	1.84	50.60	Not reported
Randomized Phase: Crizotinib 250 mg BID	13.832	Not reported	1.45	49.81	Not reported
Crossover Phase: Brigatinib 90 mg QD/180 mg QD	19.154	Not reported	1.97	33.15	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.84
upper Limit
50.60
value
33.150
group Id
OG001
lower Limit
1.45
upper Limit
49.81
value
13.832
group Id
OG002
lower Limit
1.97
upper Limit
33.15
value
19.154

denoms

counts
group Id
OG000
value
102
group Id
OG001
value
86
group Id
OG002
value
37
units
Participants

description

dispersion Type

Full Range

groups

description
Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
id
OG000
title
Randomized Phase: Brigatinib 90 mg QD/180 QD
description
Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
id
OG001
title
Randomized Phase: Crizotinib 250 mg BID
description
Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
id
OG002
title
Crossover Phase: Brigatinib 90 mg QD/180 mg QD

param Type

MEDIAN

population Description

ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Only responders were reported for this outcome measure.

reporting Status

POSTED

time Frame

Baseline up to end of study (Up to 56 months)

title

Duration of Response (DOR)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice