Participant flow

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.

groups

1. description

   Osimertinib (AZD9291) 80 mg once daily (QD) with Carboplatin (AUC of 5 mg/mL/min \[AUC5\]) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W

   id

   FG000

   title

   Safety Run-In: AZD9291 + Carboplatin + Pemetrexed

2. description

   Osimertinib (AZD9291) 80 mg once daily (QD) with Cisplatin (75 mg/m2) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W

   id

   FG001

   title

   Safety Run-In: AZD9291 + Cisplatin + Pemetrexed

3. 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

   FG002

   title

   Randomized: AZD9291 + Chemo

4. description

   Osimertinib (AZD9291) 80mg QD.

   id

   FG003

   title

   Randomized: AZD9291

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         197

      4. group Id

         FG003

         num Subjects

         191

      type

      Ongoing Study at Data Cut Off (03APR2023)

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         70

      4. group Id

         FG003

         num Subjects

         77

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Screen Failure

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         9

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         279

      4. group Id

         FG003

         num Subjects

         278

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         212

      4. comment

         Participants in this treatment did not receive Carboplatin/Cisplatin treatment.

         group Id

         FG003

         num Subjects

         0

      comment

      At Time of Data Cut Off (03APR2023)

      type

      Completed 4 Cycles of Carboplatin/Cisplatin Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         154

      4. group Id

         FG003

         num Subjects

         123

      comment

      At time of Data Cut Off (03APR2023)

      type

      Ongoing Any Study Treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         276

      4. group Id

         FG003

         num Subjects

         275

      comment

      Includes Osimertinib, Cisplatin, Carboplatin, or Pemetrexed

      type

      Received at Least One Dose of Investigational Product

   5. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      comment

      At time of Data Cut Off (03APR2023)

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         279

      4. group Id

         FG003

         num Subjects

         278

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 587 participants were enrolled in the study, 30 in the SRI and 557 in the Randomization component of the study. 6 participants were randomized to the Randomization component but did not receive any study treatment (2 Screen Failures, 2 Subject Decision, and 2 Deaths).

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Preserved source evidence · Not medical advice