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NCT03456076 · OUTCOME

Disease-free Survival (DFS), as Assessed by the Investigator

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer · Source last updated 2026-07-15

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
Approximately 58 months

What was measured

DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first

Analysis population: The ITT population consisted of all randomized participants, whether or not the participant received the assigned treatment. The Stage II-IIIa population consisted of all participants in the ITT population with Stage II-IIIa NSCLC.

Groups in this outcome

Alectinib

Participants received 600 mg oral alectinib twice daily (BID) for 2 years

Platinum-Based Chemotherapy

Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).

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

Analysis denominator · Participants

GroupSource count
Alectinib15
Platinum-Based Chemotherapy50

Reported measurements

Stage II-IIIA population

Analysis denominator · Participants

GroupSource count
Alectinib14
Platinum-Based Chemotherapy45
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AlectinibNANot reportedNANAThe number of events is too low to estimate this parameter.
Platinum-Based Chemotherapy44.4Not reported27.8NAThere was insufficient follow-up time to estimate the upper limit.
ITT population

Analysis denominator · Participants

GroupSource count
Alectinib15
Platinum-Based Chemotherapy50
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AlectinibNANot reportedNANAThe number of events is too low to estimate this parameter.
Platinum-Based Chemotherapy41.3Not reported28.5NAThere was insufficient follow-up time to estimate the upper limit.

Source statistical analyses

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

  1. ci Lower Limit
    0.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.45
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.24
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.43
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.24
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.45
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.24
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.13
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.43
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.24
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The number of events is too low to estimate this parameter.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        There was insufficient follow-up time to estimate the upper limit.
        group Id
        OG001
        lower Limit
        27.8
        upper Limit
        NA
        value
        44.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Stage II-IIIA population
  2. categories
    1. measurements
      1. comment
        The number of events is too low to estimate this parameter.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        There was insufficient follow-up time to estimate the upper limit.
        group Id
        OG001
        lower Limit
        28.5
        upper Limit
        NA
        value
        41.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        50
      units
      Participants
    title
    ITT population
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      50
    units
    Participants
description
DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 600 mg oral alectinib twice daily (BID) for 2 years
    id
    OG000
    title
    Alectinib
  2. description
    Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
    id
    OG001
    title
    Platinum-Based Chemotherapy
param Type
MEDIAN
population Description
The ITT population consisted of all randomized participants, whether or not the participant received the assigned treatment. The Stage II-IIIa population consisted of all participants in the ITT population with Stage II-IIIa NSCLC.
reporting Status
POSTED
time Frame
Approximately 58 months
title
Disease-free Survival (DFS), as Assessed by the Investigator
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice