Participant flow

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer · Source last updated 2026-08-26

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

groups

1. description

   Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)

   id

   FG000

   title

   Nivolumab + SOC Chemotherapy

2. description

   Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).

   id

   FG001

   title

   Placebo + SOC Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant withdrew consent

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant no longer met study criteria

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         229

      2. group Id

         FG001

         num Subjects

         232

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         228

      2. group Id

         FG001

         num Subjects

         230

      comment

      Continued to treatment period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Randomization

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         8

      type

      Ongoing treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         72

      type

      Disease progression/recurrence

   3. reasons

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         13

      type

      Study drug toxicity

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         14

      type

      Adverse event unrelated to study drug

   6. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         8

      type

      Participant request to discontinue study treatment

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Participant withdrew consent

   8. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Participant no longer meets study criteria

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   10. reasons

       1. group Id

          FG000

          num Subjects

          15

       2. group Id

          FG001

          num Subjects

          17

       type

       Other reasons

   11. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Administrative reason by sponsor

   12. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          0

       type

       Not reported

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         228

      2. group Id

         FG001

         num Subjects

         230

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         228

      2. group Id

         FG001

         num Subjects

         230

      type

      Neoadjuvant Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         142

      2. group Id

         FG001

         num Subjects

         152

      type

      Adjuvant Treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         85

      2. group Id

         FG001

         num Subjects

         92

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         143

      2. group Id

         FG001

         num Subjects

         138

      type

      NOT COMPLETED

   title

   Treatment

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Preserved source evidence · Not medical advice