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NCT02075840 · OUTCOME

Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants · Source last updated 2026-05-29

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)

What was measured

CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Analysis population: ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure (number of participants with measurable/non-measurable CNS lesions at baseline).

Groups in this outcome

Alectinib

Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Crizotinib

Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Alectinib152
Crizotinib151

Reported measurements

Measurable CNS lesions at baseline

Analysis denominator · Participants

GroupSource count
Alectinib21
Crizotinib22
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alectinib81.0Not reported58.0994.55Not reported
Crizotinib50.0Not reported28.2271.78Not reported
Measurable and non-measurable CNS lesions

Analysis denominator · Participants

GroupSource count
Alectinib64
Crizotinib58
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alectinib59.4Not reported46.3771.49Not reported
Crizotinib25.9Not reported15.2639.04Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.09
        upper Limit
        94.55
        value
        81.0
      2. group Id
        OG001
        lower Limit
        28.22
        upper Limit
        71.78
        value
        50.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Measurable CNS lesions at baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.37
        upper Limit
        71.49
        value
        59.4
      2. group Id
        OG001
        lower Limit
        15.26
        upper Limit
        39.04
        value
        25.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        58
      units
      Participants
    title
    Measurable and non-measurable CNS lesions
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      151
    units
    Participants
description
CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG000
    title
    Alectinib
  2. description
    Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG001
    title
    Crizotinib
param Type
NUMBER
population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure (number of participants with measurable/non-measurable CNS lesions at baseline).
reporting Status
POSTED
time Frame
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
title
Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice