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NCT01828099 · OUTCOME

Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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
From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 34 months

What was measured

PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by BIRC per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the Kaplan-Meier (KM) method.

Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.

Groups in this outcome

Ceritinib

Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

Chemotherapy

Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)

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

Analysis denominator · Participants

GroupSource count
Ceritinib189
Chemotherapy187

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ceritinib16.6Not reported12.627.2Not reported
Chemotherapy8.1Not reported5.811.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.55
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.55
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.6
        upper Limit
        27.2
        value
        16.6
      2. group Id
        OG001
        lower Limit
        5.8
        upper Limit
        11.1
        value
        8.1
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    2. group Id
      OG001
      value
      187
    units
    Participants
description
PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by BIRC per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the Kaplan-Meier (KM) method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    id
    OG000
    title
    Ceritinib
  2. description
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
reporting Status
POSTED
time Frame
From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 34 months
title
Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice