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NCT01523587 · OUTCOME

Overall Survival

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy · Source last updated 2019-02-15

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
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

What was measured

Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.

Analysis population: RS

Groups in this outcome

Afatinib

Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.

Erlotinib

Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

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

Analysis denominator · Participants

GroupSource count
Afatinib398
Erlotinib397

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Afatinib7.82Not reported7.198.71Not reported
Erlotinib6.77Not reported5.857.79Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.727
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.973
    group Description
    A Cox proportional-hazards model, stratified by race, was used to estimate the hazard ratio and 95% confidence interval (CI) between the two treatment groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0193
    p Value Comment
    P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.
    param Type
    Hazard Ratio (HR)
    param Value
    0.841
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.727
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.973
    group Description
    A Cox proportional-hazards model, stratified by race, was used to estimate the hazard ratio and 95% confidence interval (CI) between the two treatment groups.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0193
    p Value Comment
    P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.
    param Type
    Hazard Ratio (HR)
    param Value
    0.841
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.19
        upper Limit
        8.71
        value
        7.82
      2. group Id
        OG001
        lower Limit
        5.85
        upper Limit
        7.79
        value
        6.77
denoms
  1. counts
    1. group Id
      OG000
      value
      398
    2. group Id
      OG001
      value
      397
    units
    Participants
description
Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
    id
    OG000
    title
    Afatinib
  2. description
    Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
    id
    OG001
    title
    Erlotinib
param Type
MEDIAN
population Description
RS
reporting Status
POSTED
time Frame
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice