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NCT04035486 · OUTCOME

Disease Control Rate (DCR) by Investigator (Safety Run-In Treatment Arms Only)

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) · Source last updated 2026-09-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 45 months

What was measured

Disease control rate is defined as the percentage of subjects who have a best overall response of Complete response (CR) or Partial response (PR) or Stable disease (SD) by RECIST 1.1 as assessed by the Investigator. For participants with a best overall response of SD, a RECIST assessment of SD must have been observed at least 6 weeks minus 1 week (at least 35 study days) following the first dose. Per the protocol, the safety run-in treatment arms were combined and analyzed regardless of chemotherapy received for consistency with the randomized component.

Analysis population: Safety Analysis Set, includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed).

Groups in this outcome

Overall Safety Run-In Participants

Includes all participants in both Safety Run-In treatment arms: AZD9291 + Carboplatin + Pemetrexed and AZD9291 + Cisplatin + Pemetrexed

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

Analysis denominator · Participants

GroupSource count
Overall Safety Run-In Participants30

Reported measurements

Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Safety Run-In Participants3Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Safety Run-In Participants23Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Safety Run-In Participants4Not 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
    88.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    100.00
    group Description
    A 95% CI was calculated on the percentage of participants with a Response or Stable Disease using the exact (Clopper-Pearson) method.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    param Type
    Percentage of Participants
    param Value
    100.00
    statistical Method
    Clopper-Pearson
Complete source fields
analyses
  1. ci Lower Limit
    88.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    100.00
    group Description
    A 95% CI was calculated on the percentage of participants with a Response or Stable Disease using the exact (Clopper-Pearson) method.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    param Type
    Percentage of Participants
    param Value
    100.00
    statistical Method
    Clopper-Pearson
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Stable Disease (SD)
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Disease control rate is defined as the percentage of subjects who have a best overall response of Complete response (CR) or Partial response (PR) or Stable disease (SD) by RECIST 1.1 as assessed by the Investigator. For participants with a best overall response of SD, a RECIST assessment of SD must have been observed at least 6 weeks minus 1 week (at least 35 study days) following the first dose. Per the protocol, the safety run-in treatment arms were combined and analyzed regardless of chemotherapy received for consistency with the randomized component.
groups
  1. description
    Includes all participants in both Safety Run-In treatment arms: AZD9291 + Carboplatin + Pemetrexed and AZD9291 + Cisplatin + Pemetrexed
    id
    OG000
    title
    Overall Safety Run-In Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Analysis Set, includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed).
reporting Status
POSTED
time Frame
Up to 45 months
title
Disease Control Rate (DCR) by Investigator (Safety Run-In Treatment Arms Only)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice