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NCT04035486 · OUTCOME

Overall Survival (OS) (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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 45 months (maximum follow up 44.6 months)

What was measured

Overall survival is defined as the time from the date of first dose until death due to any causes. Subjects not known to have died at the time of analysis are censored at the last recorded date on which the subject was known to be alive. Median overall survival calculated using the Kaplan-Meier method. 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

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Overall Safety Run-In ParticipantsNANot reported34.0NAMedian and Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
        group Id
        OG000
        lower Limit
        34.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Overall survival is defined as the time from the date of first dose until death due to any causes. Subjects not known to have died at the time of analysis are censored at the last recorded date on which the subject was known to be alive. Median overall survival calculated using the Kaplan-Meier method. Per the protocol, the safety run-in treatment arms were combined and analyzed regardless of chemotherapy received for consistency with the randomized component.
dispersion Type
95% Confidence Interval
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
MEDIAN
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 (maximum follow up 44.6 months)
title
Overall Survival (OS) (Safety Run-In Treatment Arms Only)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice