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NCT02296125 · OUTCOME

Objective Response Rate (ORR)

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-04-21

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
95% Confidence Interval
Time frame
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression

What was measured

ORR was defined as the number (%) of participants with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. ORR was based on Investigator assessment.

Analysis population: The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.

Groups in this outcome

Osimertinib 80 mg (Global Cohort)

Randomized participants received Osimertinib 80 mg orally once daily (QD)

SoC EGFR-TKI (Global Cohort)

Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.

Osimertinib 80 mg (China Cohort)

Randomized participants received Osimertinib 80 mg orally once daily (QD)

SoC EGFR-TKI (China Cohort)

Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.

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 80 mg (Global Cohort)279
SoC EGFR-TKI (Global Cohort)277
Osimertinib 80 mg (China Cohort)71
SoC EGFR-TKI (China Cohort)65

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Osimertinib 80 mg (Global Cohort)76.7Not reported71.2981.53Not reported
SoC EGFR-TKI (Global Cohort)69.0Not reported63.1474.35Not reported
Osimertinib 80 mg (China Cohort)76.1Not reported64.585.4Not reported
SoC EGFR-TKI (China Cohort)70.8Not reported58.281.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.22
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.036
    param Type
    Odds Ratio (OR)
    param Value
    1.51
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.61
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.84
    group Ids
    1. OG002
    2. OG003
    non Inferiority Comment
    The china cohort was not powered for superiority
    non Inferiority Type
    OTHER
    p Value
    0.485
    param Type
    Odds Ratio (OR)
    param Value
    1.31
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.22
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.036
    param Type
    Odds Ratio (OR)
    param Value
    1.51
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.61
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.84
    group Ids
    1. OG002
    2. OG003
    non Inferiority Comment
    The china cohort was not powered for superiority
    non Inferiority Type
    OTHER
    p Value
    0.485
    param Type
    Odds Ratio (OR)
    param Value
    1.31
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        71.29
        upper Limit
        81.53
        value
        76.7
      2. group Id
        OG001
        lower Limit
        63.14
        upper Limit
        74.35
        value
        69.0
      3. group Id
        OG002
        lower Limit
        64.5
        upper Limit
        85.4
        value
        76.1
      4. group Id
        OG003
        lower Limit
        58.2
        upper Limit
        81.4
        value
        70.8
denoms
  1. counts
    1. group Id
      OG000
      value
      279
    2. group Id
      OG001
      value
      277
    3. group Id
      OG002
      value
      71
    4. group Id
      OG003
      value
      65
    units
    Participants
description
ORR was defined as the number (%) of participants with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. ORR was based on Investigator assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Randomized participants received Osimertinib 80 mg orally once daily (QD)
    id
    OG000
    title
    Osimertinib 80 mg (Global Cohort)
  2. description
    Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
    id
    OG001
    title
    SoC EGFR-TKI (Global Cohort)
  3. description
    Randomized participants received Osimertinib 80 mg orally once daily (QD)
    id
    OG002
    title
    Osimertinib 80 mg (China Cohort)
  4. description
    Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
    id
    OG003
    title
    SoC EGFR-TKI (China Cohort)
param Type
NUMBER
population Description
The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
reporting Status
POSTED
time Frame
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice