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: ClinicalTrials.gov results for NCT04035486 (opens in a new tab)· Licence: public-domain

First posted 6 Aug 2024 · Last update posted 3 Sep 2026 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

1. Progression-free Survival (PFS) (Randomized Component)

   Time frame

   Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.3 months)

   Measure

   Median

   Unit

   Months

   • Randomized: AZD9291 + Chemo vs Randomized: AZD9291Superiority

     The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).

     Estimate

     0.62Hazard Ratio (HR)

     95% CI, two-sided

     0.49 to 0.79

     p-value

     <0.0001

     Method

     Log Rank

2. Sensitivity Analysis for Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment (Randomized Component)

   Time frame

   Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.2 months).

   Measure

   Median

   Unit

   Months

   • Randomized: AZD9291 + Chemo vs Randomized: AZD9291Superiority

     The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).

     Estimate

     0.62Hazard Ratio (HR)

     95% CI, two-sided

     0.48 to 0.80

     p-value

     0.0002

     Method

     Log Rank

Serious adverse events

Time frame: Includes treatment emergent adverse events with onset date on or after the date of first dose and up to and including 28 days following discontinuation of treatment but prior to the start of a new anti-cancer therapy. For the Safety Run-In treatment arms, this was up to 45 months, or the data cut-off. For the Randomized treatment arms, this was up to 33 months, or the data cut-off.

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.