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NCT04035486 · OUTCOME

Landmark Overall Survival (LOS) at 1, 2, and 3 Years (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
NUMBER
Unit
percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 33 months after the first patient is randomized (maximum follow up of 34.1 months)

What was measured

Landmark Overall Survival at 1, 2, and 3 years looks at the percent of patients alive at 1, 2 and 3 year time points. Overall survival at 36 months not included to data cut off prior to 36-month timepoint. Overall survival percentage calculated using the Kaplan-Meier method.

Analysis population: Full Analysis Set, includes all randomized participants.

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 + Chemo279
Randomized: AZD9291278

Reported measurements

Overall survival at 12 months (%)
Values in percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo88.8Not reported84.492.0Not reported
Randomized: AZD929192.0Not reported88.194.7Not reported
Overall survival at 24 months (%)
Values in percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized: AZD9291 + Chemo78.9Not reported73.483.4Not reported
Randomized: AZD929173.0Not reported66.978.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        84.4
        upper Limit
        92.0
        value
        88.8
      2. group Id
        OG001
        lower Limit
        88.1
        upper Limit
        94.7
        value
        92.0
    title
    Overall survival at 12 months (%)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73.4
        upper Limit
        83.4
        value
        78.9
      2. group Id
        OG001
        lower Limit
        66.9
        upper Limit
        78.1
        value
        73.0
    title
    Overall survival at 24 months (%)
denoms
  1. counts
    1. group Id
      OG000
      value
      279
    2. group Id
      OG001
      value
      278
    units
    Participants
description
Landmark Overall Survival at 1, 2, and 3 years looks at the percent of patients alive at 1, 2 and 3 year time points. Overall survival at 36 months not included to data cut off prior to 36-month timepoint. Overall survival percentage calculated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
Full Analysis Set, includes all randomized participants.
reporting Status
POSTED
time Frame
Up to approximately 33 months after the first patient is randomized (maximum follow up of 34.1 months)
title
Landmark Overall Survival (LOS) at 1, 2, and 3 Years (Randomized Component)
type
SECONDARY
unit Of Measure
percent of participants

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

Preserved source evidence · Not medical advice