Participant flow

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR" · Source last updated 2019-10-02

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

groups

1. description

   Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.

   id

   FG000

   title

   Docetaxel

2. description

   Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.

   id

   FG001

   title

   Atezolizumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         121

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         14

      type

      Study Terminated by Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Terminated by Sponsor After 31 Aug 2018

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         143

      2. group Id

         FG001

         num Subjects

         144

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         135

      2. group Id

         FG001

         num Subjects

         142

      comment

      Two patients in the docetaxel arm crossed over to receive atezolizumab treatment.

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      comment

      Study terminated by Sponsor participants either discontinued or enrolled in extension study

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         143

      2. group Id

         FG001

         num Subjects

         144

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 527 participants were screened, of whom 287 participants were randomized. 143 participants to the docetaxel arm and 144 participants to the atezolizumab arm. Overall, 10 participants (8 in the docetaxel arm and 2 in the atezolizumab arm) did not receive any study treatment.

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

Preserved source evidence · Not medical advice