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NCT02075840 · OUTCOME

PFS Independent Review Committee (IRC)-Assessed

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
MEDIAN
Unit
months
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

PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.

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.

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

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alectinib25.7Not reported19.9NAThe upper limit of the CI could not be estimated in the alectinib arm at the time of data cutoff date (9 Feb 2017).
Crizotinib10.4Not reported7.714.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.36
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.70
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Comment
    Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.36
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.70
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Comment
    Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the CI could not be estimated in the alectinib arm at the time of data cutoff date (9 Feb 2017).
        group Id
        OG000
        lower Limit
        19.9
        upper Limit
        NA
        value
        25.7
      2. group Id
        OG001
        lower Limit
        7.7
        upper Limit
        14.6
        value
        10.4
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      151
    units
    Participants
description
PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
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
MEDIAN
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.
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
PFS Independent Review Committee (IRC)-Assessed
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice