Participant flow

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] · Source last updated 2023-03-15

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

groups

1. description

   Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).

   id

   FG000

   title

   Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

2. description

   Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

   id

   FG001

   title

   Atezolizumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         211

      2. group Id

         FG001

         num Subjects

         201

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         17

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         59

      type

      Study Terminated By Sponsor

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Local ethics requires subjects' data be removed from aug 2020 to currently.

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Participant Moved Into Roll-Over Study

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Sponsor Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         287

      2. group Id

         FG001

         num Subjects

         285

      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

         287

      2. group Id

         FG001

         num Subjects

         285

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Study is considered 'Completed' because all of the criteria for End of Study have been met. Participants in survival follow-up completed their last visit and participants on active treatment were rolled over to a rollover study to continue their treatment.

recruitment Details

Recruitment included: Japan (16 centers), Spain (15 centers), Greece (12 centers), Italy (12 centers), Brazil (11 centers), Russian (11 centers), France (10 centers), United States of America (9 centers), Ukraine (8 centers), Romania (7 centers), Turkey (6 centers), Poland (5 centers), Serbia (5 centers), Hungary (4 centers), Thailand (4 centers), Great Britain (3 centers), Republic of Korea (3 centers), Germany (2 centers), China (1 center).

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Preserved source evidence · Not medical advice