Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04035486 · OUTCOME

Progression-free Survival (PFS) by Investigator by Plasma Epidermal Growth Factor Receptor Mutation Status: Exon 19 Deletion - Participants With an Event (Randomized Component)

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 approximately 33 months after the first patient is randomized.

What was measured

PFS is defined as the time from randomization until an event. An event is defined as the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the subject withdraws from study treatment or receives another anti-cancer therapy prior to progression. Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.

Analysis population: Subgroup of Full Analysis Set, includes all randomized participants with Exon 19 Deletion EGFR mutation.

Groups in this outcome

Randomized: AZD9291 + Chemo

Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W

Randomized: AZD9291

Osimertinib (AZD9291) 80mg QD.

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

Analysis denominator · Participants

GroupSource count
Randomized: AZD9291 + Chemo172
Randomized: AZD9291169

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo65Not reportedNot reportedNot reportedNot reported
Randomized: AZD929194Not 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
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.
    group Description
    Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Cox proportional hazards model
Complete source fields
analyses
  1. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.
    group Description
    Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Cox proportional hazards model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        94
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    2. group Id
      OG001
      value
      169
    units
    Participants
description
PFS is defined as the time from randomization until an event. An event is defined as the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the subject withdraws from study treatment or receives another anti-cancer therapy prior to progression. Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.
groups
  1. description
    Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
    id
    OG000
    title
    Randomized: AZD9291 + Chemo
  2. description
    Osimertinib (AZD9291) 80mg QD.
    id
    OG001
    title
    Randomized: AZD9291
param Type
COUNT_OF_PARTICIPANTS
population Description
Subgroup of Full Analysis Set, includes all randomized participants with Exon 19 Deletion EGFR mutation.
reporting Status
POSTED
time Frame
Up to approximately 33 months after the first patient is randomized.
title
Progression-free Survival (PFS) by Investigator by Plasma Epidermal Growth Factor Receptor Mutation Status: Exon 19 Deletion - Participants With an Event (Randomized Component)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice