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NCT02220894 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042) · Source last updated 2026-06-25

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
      637
    2. group Id
      BG001
      value
      637
    3. group Id
      BG002
      value
      1274
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received carboplatin at target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W
    id
    BG001
    title
    Chemotherapy (SOC Treatment)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.9
          value
          62.5
        2. group Id
          BG001
          spread
          9.4
          value
          63.1
        3. group Id
          BG002
          spread
          9.7
          value
          62.8
    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
          187
        2. group Id
          BG001
          value
          185
        3. group Id
          BG002
          value
          372
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          450
        2. group Id
          BG001
          value
          452
        3. group Id
          BG002
          value
          902
        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
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          189
        2. group Id
          BG001
          value
          187
        3. group Id
          BG002
          value
          376
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          398
        2. group Id
          BG001
          value
          412
        3. group Id
          BG002
          value
          810
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          49
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          389
        title
        ECOG PS=0
      2. measurements
        1. group Id
          BG000
          value
          439
        2. group Id
          BG001
          value
          445
        3. group Id
          BG002
          value
          884
        title
        ECOG PS=1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        ECOG PS=2
    description
    Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature; Grade 2: Ambulatory \& capable of all selfcare but unable to carry out any work activities, up \& about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair or Grade 5: Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          299
        2. group Id
          BG001
          value
          300
        3. group Id
          BG002
          value
          599
        title
        TPS=≥50%
      2. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          219
        title
        TPS=20-49%
      3. measurements
        1. group Id
          BG000
          value
          224
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          456
        title
        TPS=1-19%
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        TPS=<1%
    description
    Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using tumor tissue from an archival or newly obtained biopsy. Participants with a tumor proportion score (TPS) were classified as follows: ≥50% = PD-L1 strongly positive; 1-49% = PD-L1 weakly positive; and \<1% = PD-L1 negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          249
        3. group Id
          BG002
          value
          491
        title
        Squamous
      2. measurements
        1. group Id
          BG000
          value
          395
        2. group Id
          BG001
          value
          388
        3. group Id
          BG002
          value
          783
        title
        Non-squamous
    description
    Participants were classified according to tumor histology: Squamous or Non-squamous. The tumor histology determined potential treatment regimen.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Histology
    unit Of Measure
    Participants
population Description
The Baseline Analysis Population consisted of all randomized participants who were alive at the time of randomization and had a Tumor Proportion Score (TPS) ≥1%.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      637
    2. group Id
      BG001
      value
      637
    3. group Id
      BG002
      value
      1274
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received carboplatin at target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W
    id
    BG001
    title
    Chemotherapy (SOC Treatment)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.9
          value
          62.5
        2. group Id
          BG001
          spread
          9.4
          value
          63.1
        3. group Id
          BG002
          spread
          9.7
          value
          62.8
    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
          187
        2. group Id
          BG001
          value
          185
        3. group Id
          BG002
          value
          372
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          450
        2. group Id
          BG001
          value
          452
        3. group Id
          BG002
          value
          902
        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
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          189
        2. group Id
          BG001
          value
          187
        3. group Id
          BG002
          value
          376
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          398
        2. group Id
          BG001
          value
          412
        3. group Id
          BG002
          value
          810
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          49
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          389
        title
        ECOG PS=0
      2. measurements
        1. group Id
          BG000
          value
          439
        2. group Id
          BG001
          value
          445
        3. group Id
          BG002
          value
          884
        title
        ECOG PS=1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        ECOG PS=2
    description
    Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature; Grade 2: Ambulatory \& capable of all selfcare but unable to carry out any work activities, up \& about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair or Grade 5: Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          299
        2. group Id
          BG001
          value
          300
        3. group Id
          BG002
          value
          599
        title
        TPS=≥50%
      2. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          219
        title
        TPS=20-49%
      3. measurements
        1. group Id
          BG000
          value
          224
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          456
        title
        TPS=1-19%
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        TPS=<1%
    description
    Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using tumor tissue from an archival or newly obtained biopsy. Participants with a tumor proportion score (TPS) were classified as follows: ≥50% = PD-L1 strongly positive; 1-49% = PD-L1 weakly positive; and \<1% = PD-L1 negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          249
        3. group Id
          BG002
          value
          491
        title
        Squamous
      2. measurements
        1. group Id
          BG000
          value
          395
        2. group Id
          BG001
          value
          388
        3. group Id
          BG002
          value
          783
        title
        Non-squamous
    description
    Participants were classified according to tumor histology: Squamous or Non-squamous. The tumor histology determined potential treatment regimen.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Histology
    unit Of Measure
    Participants
population Description
The Baseline Analysis Population consisted of all randomized participants who were alive at the time of randomization and had a Tumor Proportion Score (TPS) ≥1%.

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Preserved source evidence · Not medical advice