Participant flow

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-04-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Randomized participants received Osimertinib 80 mg orally once daily (QD)

   id

   FG000

   title

   Osimertinib 80 mg (Global Cohort)

2. description

   Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.

   id

   FG001

   title

   SoC EGFR-TKI (Global Cohort)

3. description

   Randomized participants received Osimertinib 80 mg orally once daily (QD)

   id

   FG002

   title

   Osimertinib 80 mg (China Cohort)

4. description

   Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.

   id

   FG003

   title

   SoC EGFR-TKI (China Cohort)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         2

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         52

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         4

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Severe non-compliance to protocol

   4. reasons

      1. group Id

         FG000

         num Subjects

         153

      2. group Id

         FG001

         num Subjects

         199

      3. group Id

         FG002

         num Subjects

         39

      4. group Id

         FG003

         num Subjects

         56

      type

      Condition under investigation worsened

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      type

      Any reason not specifically recorded

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         279

      2. comment

         183 participant received gefitinib and 93 participants received erlotinib.

         group Id

         FG001

         num Subjects

         277

      3. comment

         There were 12 participants who were in both the Global and China Extension Osimertinib Arm.

         group Id

         FG002

         num Subjects

         71

      4. comment

         There were 7 participants who were in both the Global and China Extension SoC EGFR-TKI Arm.

         group Id

         FG003

         num Subjects

         65

      comment

      There were 19 participants double counted which shows the total participants of 692.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         61

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         15

      4. group Id

         FG003

         num Subjects

         3

      comment

      Participants ongoing study treatment at data cut-off

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         218

      2. group Id

         FG001

         num Subjects

         264

      3. group Id

         FG002

         num Subjects

         56

      4. group Id

         FG003

         num Subjects

         62

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

During the 28 day screening period, participants were enrolled based on the presence in their tumour of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations. At the time of enrolment, all participants were required to provide biopsy tissue for central testing of the Exon 19 deletion (Ex19del) and L858R mutations

recruitment Details

A total of 556 participants in Global cohort (out of 673 participants in Global and China cohorts) were randomized to treatment at 132 study centres in 29 countries. An additional 117 participants in 19 centres were enrolled into the China extension cohort only.

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Preserved source evidence · Not medical advice