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NCT02151981 · OUTCOME

Time to Second Subsequent Therapy (TSST)

AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-01-07

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 date of randomisation until time of final OS analysis, a median follow-up of 43 months

What was measured

Time from randomisation to second subsequent anti-cancer therapy (SST) following randomised treatment discontinuation, or death if no SST administered. Any patient not known to have died nor received any SST was censored at the last time known not to have received SST, ie, the last follow-up visit this was confirmed.

Analysis population: Full Analysis set (All randomised patients)

Groups in this outcome

Osimertinib 80mg

Daily single dose of Osimertinib 80mg

Chemotherapy

Platinum-based doublet chemotherapy

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

Analysis denominator · Participants

GroupSource count
Osimertinib 80mg279
Chemotherapy140

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Osimertinib 80mg20.0Not reported17.223.2Not reported
Chemotherapy19.0Not reported16.522.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.11
    estimate Comment
    A hazard ratio \<1 favours Osimertinib 80 mg
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.11
    estimate Comment
    A hazard ratio \<1 favours Osimertinib 80 mg
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.2
        upper Limit
        23.2
        value
        20.0
      2. group Id
        OG001
        lower Limit
        16.5
        upper Limit
        22.0
        value
        19.0
denoms
  1. counts
    1. group Id
      OG000
      value
      279
    2. group Id
      OG001
      value
      140
    units
    Participants
description
Time from randomisation to second subsequent anti-cancer therapy (SST) following randomised treatment discontinuation, or death if no SST administered. Any patient not known to have died nor received any SST was censored at the last time known not to have received SST, ie, the last follow-up visit this was confirmed.
dispersion Type
95% Confidence Interval
groups
  1. description
    Daily single dose of Osimertinib 80mg
    id
    OG000
    title
    Osimertinib 80mg
  2. description
    Platinum-based doublet chemotherapy
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
Full Analysis set (All randomised patients)
reporting Status
POSTED
time Frame
From date of randomisation until time of final OS analysis, a median follow-up of 43 months
title
Time to Second Subsequent Therapy (TSST)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Months

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

Preserved source evidence · Not medical advice