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NCT03066778 · BASELINE

Baseline characteristics

A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604) · Source last updated 2022-10-03

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

denoms
  1. counts
    1. group Id
      BG000
      value
      228
    2. group Id
      BG001
      value
      225
    3. group Id
      BG002
      value
      453
    units
    Participants
groups
  1. description
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    id
    BG000
    title
    Pembrolizumab+EP
  2. description
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    id
    BG001
    title
    Placebo+EP
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.4
          value
          64.2
        2. group Id
          BG001
          spread
          8.2
          value
          65.2
        3. group Id
          BG002
          spread
          8.3
          value
          64.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          152
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          294
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          19
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          204
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          396
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          38
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          86
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          339
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          26
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          116
      title
      ECOG = 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          168
        2. group Id
          BG001
          value
          169
        3. group Id
          BG002
          value
          337
      title
      ECOG = 1
    description
    An ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the study and randomization was stratified by ECOG score.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          195
      title
      LDH = ≤ Upper Limit of Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          127
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          256
      title
      LDH = > Upper Limit of Normal
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      LDH Result Missing
    description
    Randomization of participants in the study was stratified by LDH measurement at baseline ( ≤ or \> upper limit of normal).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lactate Dehydrogenase (LDH) Status at Baseline
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          129
      title
      Cisplatin
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          317
      title
      Carboplatin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      Not Treated with Platinum Therapy
    description
    Randomization of participants was stratified by type of platinum therapy administered during the study.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Platinum Therapy Administered
    unit Of Measure
    Participants
population Description
All participants randomized by intention to treat (ITT).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      228
    2. group Id
      BG001
      value
      225
    3. group Id
      BG002
      value
      453
    units
    Participants
groups
  1. description
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    id
    BG000
    title
    Pembrolizumab+EP
  2. description
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    id
    BG001
    title
    Placebo+EP
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.4
          value
          64.2
        2. group Id
          BG001
          spread
          8.2
          value
          65.2
        3. group Id
          BG002
          spread
          8.3
          value
          64.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          152
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          294
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          19
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          204
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          396
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          38
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          86
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          339
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          26
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          116
      title
      ECOG = 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          168
        2. group Id
          BG001
          value
          169
        3. group Id
          BG002
          value
          337
      title
      ECOG = 1
    description
    An ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the study and randomization was stratified by ECOG score.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          195
      title
      LDH = ≤ Upper Limit of Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          127
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          256
      title
      LDH = > Upper Limit of Normal
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      LDH Result Missing
    description
    Randomization of participants in the study was stratified by LDH measurement at baseline ( ≤ or \> upper limit of normal).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lactate Dehydrogenase (LDH) Status at Baseline
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          129
      title
      Cisplatin
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          317
      title
      Carboplatin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      Not Treated with Platinum Therapy
    description
    Randomization of participants was stratified by type of platinum therapy administered during the study.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Platinum Therapy Administered
    unit Of Measure
    Participants
population Description
All participants randomized by intention to treat (ITT).

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Preserved source evidence · Not medical advice