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NCT02737501 · OUTCOME

Time to Response (TTR)

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 treatment (Up to 36 months)

What was measured

Time to response as assessed by BIRC, assessment and is defined as the time interval from the date of randomization until the initial observation of CR or PR. 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.

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

GroupSource count
Randomized Phase: Brigatinib 90 mg QD/180 QD137
Randomized Phase: Crizotinib 250 mg BID138
Crossover Phase: Brigatinib 90 mg QD/180 mg QD65

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Randomized Phase: Brigatinib 90 mg QD/180 QD1.840Not reported1.0229.47Not reported
Randomized Phase: Crizotinib 250 mg BID1.873Not reported0.797.43Not reported
Crossover Phase: Brigatinib 90 mg QD/180 mg QD1.873Not reported0.2018.33Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.02
        upper Limit
        29.47
        value
        1.840
      2. group Id
        OG001
        lower Limit
        0.79
        upper Limit
        7.43
        value
        1.873
      3. group Id
        OG002
        lower Limit
        0.20
        upper Limit
        18.33
        value
        1.873
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      138
    3. group Id
      OG002
      value
      65
    units
    Participants
description
Time to response as assessed by BIRC, assessment and is defined as the time interval from the date of randomization until the initial observation of CR or PR. 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.
dispersion Type
Full Range
groups
  1. 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
  2. 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
  3. 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 treatment (Up to 36 months)
title
Time to Response (TTR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice