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NCT01802632 · OUTCOME

Objective Response Rate (ORR) for Dose Expansion 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 21 months (at 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 investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

Analysis population: All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.

Groups in this outcome

Dose Expansion

Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.

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

Analysis denominator · Participants

GroupSource count
Dose Expansion175

Reported measurements

Source class 1
Values in % of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Expansion61.7Not reported54.168.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.1
        upper Limit
        68.9
        value
        61.7
denoms
  1. counts
    1. group Id
      OG000
      value
      175
    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 investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
    id
    OG000
    title
    Dose Expansion
param Type
NUMBER
population Description
All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.
reporting Status
POSTED
time Frame
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
title
Objective Response Rate (ORR) for Dose Expansion Population
type
PRIMARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice