Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01802632 · OUTCOME

Best Objective Response (BOR) for 80mg AZD9291 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
Not reported
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; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to 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 investigator assessment) 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 Extension201

Reported measurements

Complete Response
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
80mg AZD9291 Extension1.0Not reportedNot reportedNot reportedNot reported
Partial response
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
80mg AZD9291 Extension70.1Not reportedNot reportedNot reportedNot reported
Stable disease
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
80mg AZD9291 Extension21.9Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
80mg AZD9291 Extension6.5Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
80mg AZD9291 Extension0.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        70.1
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        21.9
    title
    Stable disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6.5
    title
    Progressive disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.5
    title
    Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      201
    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; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.
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 investigator assessment) 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
Best Objective Response (BOR) for 80mg AZD9291 Extension Population
type
SECONDARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice