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NCT02737501 · OUTCOME

Progression-free Survival (PFS)

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
Up to end of study (Up to 56 months)

What was measured

PFS as assessed by Blinded Independent Review Committee (BIRC), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, was defined as the time interval from the date of randomization until the date of the first documented PD event. The data was censored for participants without a PFS event.

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 QD24.016Not reported18.4643.20Not reported
Randomized Phase: Crizotinib 250 mg BID11.072Not reported9.1313.01Not reported
Crossover Phase: Brigatinib 90 mg QD/180 mg QD16.821Not reported10.1223.85Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.35
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.66
    estimate Comment
    The hazard ratio was obtained using a Cox proportional hazards model with randomization stratification factors (current) as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P-values are from a log-rank test stratified by randomization stratification factors (current; presence of intracranial central nervous system (iCNS) metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).
    param Type
    Hazard Ratio (HR)
    param Value
    0.481
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.35
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.66
    estimate Comment
    The hazard ratio was obtained using a Cox proportional hazards model with randomization stratification factors (current) as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P-values are from a log-rank test stratified by randomization stratification factors (current; presence of intracranial central nervous system (iCNS) metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).
    param Type
    Hazard Ratio (HR)
    param Value
    0.481
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.46
        upper Limit
        43.20
        value
        24.016
      2. group Id
        OG001
        lower Limit
        9.13
        upper Limit
        13.01
        value
        11.072
      3. group Id
        OG002
        lower Limit
        10.12
        upper Limit
        23.85
        value
        16.821
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      138
    3. group Id
      OG002
      value
      65
    units
    Participants
description
PFS as assessed by Blinded Independent Review Committee (BIRC), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, was defined as the time interval from the date of randomization until the date of the first documented PD event. The data was censored for participants without a PFS event.
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
Up to end of study (Up to 56 months)
title
Progression-free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice