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NCT00525148 · OUTCOME

Time to Objective Response

LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations · Source last updated 2016-09-16

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
Not reported
Time frame
Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.

What was measured

Time to objective response was defined as the number of days from the start of treatment to the first recorded objective response. Patients who did not experience objective response during the study were censored at the time of treatment discontinuation. The results are provided as the percentage of participants for this Outcome Measure.

Analysis population: Treated set

Groups in this outcome

Afatinib

Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.

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

Analysis denominator · Participants

GroupSource count
Afatinib129

Reported measurements

Week 4
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib38.8Not reportedNot reportedNot reportedNot reported
Week 8
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib12.4Not reportedNot reportedNot reportedNot reported
Week 12
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib1.6Not reportedNot reportedNot reportedNot reported
Week 20
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib5.4Not reportedNot reportedNot reportedNot reported
Week 28
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib0.0Not reportedNot reportedNot reportedNot reported
Week 36
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib1.6Not reportedNot reportedNot reportedNot reported
Week 44
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib0.0Not reportedNot reportedNot reportedNot reported
>= Week 52
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib2.3Not reportedNot reportedNot reportedNot reported
no objective response
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib38.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38.8
    title
    Week 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12.4
    title
    Week 8
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
    title
    Week 12
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5.4
    title
    Week 20
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
    title
    Week 28
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
    title
    Week 36
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
    title
    Week 44
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2.3
    title
    >= Week 52
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        38.0
    title
    no objective response
denoms
  1. counts
    1. group Id
      OG000
      value
      129
    units
    Participants
description
Time to objective response was defined as the number of days from the start of treatment to the first recorded objective response. Patients who did not experience objective response during the study were censored at the time of treatment discontinuation. The results are provided as the percentage of participants for this Outcome Measure.
groups
  1. description
    Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
    id
    OG000
    title
    Afatinib
param Type
NUMBER
population Description
Treated set
reporting Status
POSTED
time Frame
Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.
title
Time to Objective Response
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice