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NCT02151981 · OUTCOME

Objective Response Rate (ORR) by Investigator Assessment

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
NUMBER
Unit
% of participants
Interval / dispersion
Not reported
Time frame
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).

What was measured

Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.

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 % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Osimertinib 80mg70.6Not reportedNot reportedNot reportedNot reported
Chemotherapy31.4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    3.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.48
    estimate Comment
    odds ratio \>1.0 favours Osimertinib 80 mg
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    5.39
    statistical Comment
    adjusted for ethnicity (Asian/non-Asian)
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    3.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.48
    estimate Comment
    odds ratio \>1.0 favours Osimertinib 80 mg
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    5.39
    statistical Comment
    adjusted for ethnicity (Asian/non-Asian)
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        70.6
      2. group Id
        OG001
        value
        31.4
denoms
  1. counts
    1. group Id
      OG000
      value
      279
    2. group Id
      OG001
      value
      140
    units
    Participants
description
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.
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
NUMBER
population Description
Full Analysis Set (All randomised patients)
reporting Status
POSTED
time Frame
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
title
Objective Response Rate (ORR) by Investigator Assessment
type
SECONDARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice