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NCT02737501 · OUTCOME

Overall Survival (OS)

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
95% Confidence Interval
Time frame
Baseline up to end of study (Up to 56 months)

What was measured

Overall survival is defined as the time from randomization until death due to any cause.

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.

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: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized Phase: Brigatinib 90 mg QD/180 QDNANot reportedNANAMedian and 95% CI was not estimable due to fewer number of participants with events.
Randomized Phase: Crizotinib 250 mg BIDNANot reportedNANAMedian and 95% CI was not estimable due to fewer number of participants with events.
Crossover Phase: Brigatinib 90 mg QD/180 mg QD35.023Not reported30.42NAUpper limit of 95% CI was not estimable due to fewer number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and 95% CI was not estimable due to fewer number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median and 95% CI was not estimable due to fewer number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Upper limit of 95% CI was not estimable due to fewer number of participants with events.
        group Id
        OG002
        lower Limit
        30.42
        upper Limit
        NA
        value
        35.023
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      138
    3. group Id
      OG002
      value
      65
    units
    Participants
description
Overall survival is defined as the time from randomization until death due to any cause.
dispersion Type
95% Confidence Interval
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.
reporting Status
POSTED
time Frame
Baseline up to end of study (Up to 56 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice