Participant flow

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer · Source last updated 2023-10-10

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

groups

1. description

   Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.

   id

   FG000

   title

   Durvalumab (MEDI4736)

2. description

   Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         16

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         3

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         260

      2. group Id

         FG001

         num Subjects

         149

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Missing Termination Reason

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         476

      2. group Id

         FG001

         num Subjects

         237

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         476

      2. group Id

         FG001

         num Subjects

         237

      type

      Full Analysis Set (FAS)

   3. achievements

      1. group Id

         FG000

         num Subjects

         473

      2. group Id

         FG001

         num Subjects

         236

      type

      Received Treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         475

      2. group Id

         FG001

         num Subjects

         234

      type

      Safety Analysis Set

   5. achievements

      1. group Id

         FG000

         num Subjects

         232

      2. group Id

         FG001

         num Subjects

         82

      type

      Completed 12 Months of Treatment

   6. achievements

      1. group Id

         FG000

         num Subjects

         178

      2. group Id

         FG001

         num Subjects

         68

      comment

      Ongoing study at final DCO (study complete)

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         298

      2. group Id

         FG001

         num Subjects

         169

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Eligible patients with locally advanced, unresectable Stage III non-small cell lung cancer were randomized in a 2:1 ratio to receive either durvalumab (MEDI4736) 10 milligrams (mg) / kilogram (kg) every 2 weeks (Q2W) or placebo.

recruitment Details

Patients were randomized between 09 May 2014 and 22 Apr 2016 in 235 study centers across 26 countries. Data cut-off (DCO) date for analysis of progression-free survival (PFS) and PFS rates at 12 and 18 months: 13 Feb 2017; DCO date for analysis of overall survival (OS) and all other secondary outcome measures: 22 Mar 2018; DCO date for completion of long-term survival: 11 Jan 2021.

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Preserved source evidence · Not medical advice