Participant flow

Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010) · Source last updated 2021-10-06

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

groups

1. description

   Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.

   id

   FG000

   title

   Pembrolizumab 2 mg/kg

2. description

   Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.

   id

   FG001

   title

   Pembrolizumab 10 mg/kg

3. description

   Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.

   id

   FG002

   title

   Docetaxel 75 mg/m^2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         18

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         103

      2. group Id

         FG001

         num Subjects

         78

      3. group Id

         FG002

         num Subjects

         59

      type

      Clinical Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         43

      3. group Id

         FG002

         num Subjects

         47

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         9

      type

      Excluded Medication

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         12

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Protocol Violation

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Screen Failure

   9. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         21

      3. group Id

         FG002

         num Subjects

         53

      type

      Withdrawal by Subject

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       3. group Id

          FG002

          num Subjects

          0

       type

       Sponsor Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         345

      2. group Id

         FG001

         num Subjects

         346

      3. group Id

         FG002

         num Subjects

         343

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         339

      2. group Id

         FG001

         num Subjects

         343

      3. group Id

         FG002

         num Subjects

         309

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         0

      type

      Received Second Course of Pembrolizumab

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         8

      type

      Switched Over to Pembrolizumab

   5. achievements

      1. group Id

         FG000

         num Subjects

         142

      2. group Id

         FG001

         num Subjects

         159

      3. group Id

         FG002

         num Subjects

         143

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         203

      2. group Id

         FG001

         num Subjects

         187

      3. group Id

         FG002

         num Subjects

         200

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Per protocol, response or progression during the second and switch over pembrolizumab courses was not counted towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses were not counted towards safety outcome measures. Final analyses for all primary and secondary outcome measures was done at the protocol-specified cutoff of 30-Sep-2015.

recruitment Details

Participants who had non-small cell lung cancer (NSCLC) and whose tumors were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.

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Preserved source evidence · Not medical advice