Participant flow

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2025-10-30

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

groups

1. description

   Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.

   id

   FG000

   title

   Part 1-Arm B: Nivo + Ipi

2. description

   Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.

   id

   FG001

   title

   Part 1-Arm A: Nivolumab

3. description

   Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.

   id

   FG002

   title

   Part 1-Arm C: Chemotherapy

4. description

   Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.

   id

   FG003

   title

   Part 1-Arm D: Nivo + Ipi

5. description

   Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.

   id

   FG004

   title

   Part 1-Arm G: Nivo + Chemo

6. description

   Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.

   id

   FG005

   title

   Part 1-Arm F: Chemotherapy

7. description

   Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.

   id

   FG006

   title

   Part 2 - Arm H: Nivolumab + Chemotherapy

8. description

   Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.

   id

   FG007

   title

   Part 2 - Arm I: Chemotherapy

9. description

   Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.

   id

   FG008

   title

   Part 3 -Arm J: Nivolumab + Ipilimumab

10. description

    Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.

    id

    FG009

    title

    Part 3 - Arm K: Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Adverse events unrelated to study drug

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Other reasons

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Subject no longer meets study criteria

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          3

      type

      Subject withdrew consent

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          1

      type

      Subject request to discontinue study treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         396

      2. group Id

         FG001

         num Subjects

         396

      3. group Id

         FG002

         num Subjects

         397

      4. group Id

         FG003

         num Subjects

         187

      5. group Id

         FG004

         num Subjects

         177

      6. group Id

         FG005

         num Subjects

         186

      7. group Id

         FG006

         num Subjects

         377

      8. group Id

         FG007

         num Subjects

         378

      9. group Id

         FG008

         num Subjects

         126

      10. group Id

          FG009

          num Subjects

          127

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         391

      2. group Id

         FG001

         num Subjects

         391

      3. group Id

         FG002

         num Subjects

         387

      4. group Id

         FG003

         num Subjects

         185

      5. group Id

         FG004

         num Subjects

         172

      6. group Id

         FG005

         num Subjects

         183

      7. group Id

         FG006

         num Subjects

         375

      8. group Id

         FG007

         num Subjects

         371

      9. group Id

         FG008

         num Subjects

         126

      10. group Id

          FG009

          num Subjects

          123

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         7

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          4

      type

      NOT COMPLETED

   title

   Pre-Treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         14

      8. group Id

         FG007

         num Subjects

         8

      9. group Id

         FG008

         num Subjects

         5

      10. group Id

          FG009

          num Subjects

          2

      type

      Not reported

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         7

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         8

      8. group Id

         FG007

         num Subjects

         8

      9. group Id

         FG008

         num Subjects

         21

      10. group Id

          FG009

          num Subjects

          1

      type

      Other reasons

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Administrative reason by sponsor

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Participant meet no longer study criteria

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          1

      type

      Poor/Non Compliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         3

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          2

      type

      Maximum Clinical Benefit

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         3

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          3

      type

      Participant withdrew Consent

   9. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         15

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         13

      8. group Id

         FG007

         num Subjects

         15

      9. group Id

         FG008

         num Subjects

         4

      10. group Id

          FG009

          num Subjects

          18

      type

      Participant request to discontinue treatment

   10. reasons

       1. group Id

          FG000

          num Subjects

          23

       2. group Id

          FG001

          num Subjects

          29

       3. group Id

          FG002

          num Subjects

          22

       4. group Id

          FG003

          num Subjects

          18

       5. group Id

          FG004

          num Subjects

          11

       6. group Id

          FG005

          num Subjects

          15

       7. group Id

          FG006

          num Subjects

          25

       8. group Id

          FG007

          num Subjects

          19

       9. group Id

          FG008

          num Subjects

          4

       10. group Id

           FG009

           num Subjects

           2

       type

       Adverse event unrelated to study drug

   11. reasons

       1. group Id

          FG000

          num Subjects

          4

       2. group Id

          FG001

          num Subjects

          7

       3. group Id

          FG002

          num Subjects

          0

       4. group Id

          FG003

          num Subjects

          0

       5. group Id

          FG004

          num Subjects

          1

       6. group Id

          FG005

          num Subjects

          2

       7. group Id

          FG006

          num Subjects

          6

       8. group Id

          FG007

          num Subjects

          5

       9. group Id

          FG008

          num Subjects

          9

       10. group Id

           FG009

           num Subjects

           0

       type

       Death

   12. reasons

       1. group Id

          FG000

          num Subjects

          79

       2. group Id

          FG001

          num Subjects

          51

       3. group Id

          FG002

          num Subjects

          31

       4. group Id

          FG003

          num Subjects

          39

       5. group Id

          FG004

          num Subjects

          12

       6. group Id

          FG005

          num Subjects

          25

       7. group Id

          FG006

          num Subjects

          52

       8. group Id

          FG007

          num Subjects

          30

       9. group Id

          FG008

          num Subjects

          20

       10. group Id

           FG009

           num Subjects

           9

       type

       Study Drug Toxicity

   Show more (12 of 15)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         391

      2. group Id

         FG001

         num Subjects

         391

      3. group Id

         FG002

         num Subjects

         387

      4. group Id

         FG003

         num Subjects

         185

      5. group Id

         FG004

         num Subjects

         172

      6. group Id

         FG005

         num Subjects

         183

      7. group Id

         FG006

         num Subjects

         375

      8. group Id

         FG007

         num Subjects

         371

      9. group Id

         FG008

         num Subjects

         126

      10. group Id

          FG009

          num Subjects

          123

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         37

      3. group Id

         FG002

         num Subjects

         94

      4. group Id

         FG003

         num Subjects

         14

      5. group Id

         FG004

         num Subjects

         20

      6. group Id

         FG005

         num Subjects

         32

      7. group Id

         FG006

         num Subjects

         40

      8. group Id

         FG007

         num Subjects

         83

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          37

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         346

      2. group Id

         FG001

         num Subjects

         354

      3. group Id

         FG002

         num Subjects

         293

      4. group Id

         FG003

         num Subjects

         171

      5. group Id

         FG004

         num Subjects

         152

      6. group Id

         FG005

         num Subjects

         151

      7. group Id

         FG006

         num Subjects

         335

      8. group Id

         FG007

         num Subjects

         288

      9. group Id

         FG008

         num Subjects

         126

      10. group Id

          FG009

          num Subjects

          86

      type

      NOT COMPLETED

   title

   Treatment Period

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Preserved source evidence · Not medical advice