Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01802632 · OUTCOME

Objective Response Rate (ORR) for Extension Population

AZD9291 First Time In Patients Ascending Dose Study · Source last updated 2026-04-20

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 randomisation until objective disease progression, up to approximately 12 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 (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

Analysis population: All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by independent central review) at baseline.

Groups in this outcome

80mg AZD9291 Extension

Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.

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

Analysis denominator · Participants

GroupSource count
80mg AZD9291 Extension198

Reported measurements

Source class 1
Values in % of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
80mg AZD9291 Extension61.6Not reported54.568.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.5
        upper Limit
        68.4
        value
        61.6
denoms
  1. counts
    1. group Id
      OG000
      value
      198
    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 (by independent central 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
    Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
    id
    OG000
    title
    80mg AZD9291 Extension
param Type
NUMBER
population Description
All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by independent central review) at baseline.
reporting Status
POSTED
time Frame
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)
title
Objective Response Rate (ORR) for Extension Population
type
PRIMARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice