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NCT02075840 · OUTCOME

Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators 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

ORR was defined as the percentage of participants who attained CR or PR. 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.

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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alectinib82.9Not reported75.9588.51Not reported
Crizotinib75.5Not reported67.8482.12Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -1.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.50
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0936
    p Value Comment
    Stratified analysis
    param Type
    Difference in Overall Response Rates
    param Value
    7.40
    statistical Method
    Mantel Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    -1.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.50
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0936
    p Value Comment
    Stratified analysis
    param Type
    Difference in Overall Response Rates
    param Value
    7.40
    statistical Method
    Mantel Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        75.95
        upper Limit
        88.51
        value
        82.9
      2. group Id
        OG001
        lower Limit
        67.84
        upper Limit
        82.12
        value
        75.5
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      151
    units
    Participants
description
ORR was defined as the percentage of participants who attained CR or PR. 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.
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 Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators 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