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NCT02094261 · OUTCOME

Objective Response Rate (ORR)

Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours · Source last updated 2024-11-06

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
95% Confidence Interval
Time frame
RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of 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 (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

Analysis population: All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.

Groups in this outcome

AZD9291 80mg

Daily single dose of AZD9291 80mg

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

Analysis denominator · Participants

GroupSource count
AZD9291 80mg199

Reported measurements

Source class 1
Values in % of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AZD9291 80mg70.9Not reported64.077.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.0
        upper Limit
        77.1
        value
        70.9
denoms
  1. counts
    1. group Id
      OG000
      value
      199
    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 (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Daily single dose of AZD9291 80mg
    id
    OG000
    title
    AZD9291 80mg
param Type
NUMBER
population Description
All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.
reporting Status
POSTED
time Frame
RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice