Participant flow

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-08-09

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

groups

1. description

   Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

   id

   FG000

   title

   Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)

2. description

   Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.

   id

   FG001

   title

   Arm B (Nab-Paclitaxel+Carboplatin)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         13

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         4

      type

      Randomized in Error

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-Compliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         330

      2. group Id

         FG001

         num Subjects

         176

      type

      Death

   8. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         5

      type

      Patient Moving to Roll-Over Study

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Prolonged Hospitalization

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Death Prior First Dose

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Administrative-Change Facility

   12. reasons

       1. group Id

          FG000

          num Subjects

          78

       2. group Id

          FG001

          num Subjects

          29

       type

       Request From Sponsor to Withdraw Patient in Survival Follow-Up

   Show more (12 of 17)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         483

      2. group Id

         FG001

         num Subjects

         240

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         483

      2. group Id

         FG001

         num Subjects

         240

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants in this study included: histologically or cytologically confirmed, Stage IV non-squamous NSCLC; and no prior treatment for Stage IV non-squamous NSCLC. At the time of study completion a few participants that were still on maintenance treatment with atezolizumab were moved to another study, Post-Trial Access Program, or commercial use. Therefore, the reason for discontinuation was entered "Study terminated by Sponsor" for these participants.

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

Preserved source evidence · Not medical advice