Participant flow

AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-01-07

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

groups

1. description

   Daily single dose of Osimertinib 80mg

   id

   FG000

   title

   Osimertinib 80 mg

2. description

   Platinum-based doublet chemotherapy

   id

   FG001

   title

   Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         184

      2. group Id

         FG001

         num Subjects

         88

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         21

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Eligibility criteria not fulfilled

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         279

      2. group Id

         FG001

         num Subjects

         140

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         279

      2. group Id

         FG001

         num Subjects

         136

      type

      Received Randomised Treatment Only

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Did Not Receive Treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. comment

         Patients randomised to chemotherapy were allowed to crossover to Osimertinib after progression

         group Id

         FG001

         num Subjects

         99

      type

      Crossed Over Osimertinib

   5. achievements

      1. group Id

         FG000

         num Subjects

         60

      2. group Id

         FG001

         num Subjects

         27

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         219

      2. group Id

         FG001

         num Subjects

         113

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

First patient dosed: 20 August 2014. Data cut off: 15 March 2019. Open for enrolment at 145 study centres, 126 centres in 17 countries randomised patients to treatment. Following the final OS analysis, patients were permitted to continue to receive treatment if, in the investigator's opinion, they were continuing to receive benefit from treatment. The last patient completed the study on the 15 December 2023

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

Preserved source evidence · Not medical advice