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NCT02578680 · BASELINE

Baseline characteristics

Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189) · Source last updated 2024-09-20

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
      410
    2. group Id
      BG001
      value
      206
    3. group Id
      BG002
      value
      616
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
    id
    BG000
    title
    Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed
  2. description
    Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
    id
    BG001
    title
    Control
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          63.2
        2. group Id
          BG001
          spread
          9.1
          value
          62.8
        3. group Id
          BG002
          spread
          9.3
          value
          63.1
    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
          156
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          253
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          254
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          363
        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
          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
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        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
          11
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          387
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          582
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        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
          127
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          190
      title
      TPS <1%
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          388
      title
      TPS ≥1%
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          38
      title
      Not Evaluable
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from an archival or newly obtained biopsy. Participants with a TPS ≥1% were classified as PD-L1 positive and participants with a TPS \<1% were classified as PD-L1 negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          113
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          171
      title
      Cisplatin
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          445
      title
      Carboplatin
    description
    Participants were classified according to the type of platinum chemotherapy the Investigator chose for them to receive: Cisplatin or Carboplatin.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Platinum Chemotherapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          73
      title
      Never Smoker
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          362
        2. group Id
          BG001
          value
          181
        3. group Id
          BG002
          value
          543
      title
      Former/Current Smoker
    description
    Participants were classified according to their smoking status: Never Smoker or Former/Current Smoker.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Status
    unit Of Measure
    Participants
population Description
The Baseline Analysis Population consisted of all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      410
    2. group Id
      BG001
      value
      206
    3. group Id
      BG002
      value
      616
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
    id
    BG000
    title
    Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed
  2. description
    Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
    id
    BG001
    title
    Control
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          63.2
        2. group Id
          BG001
          spread
          9.1
          value
          62.8
        3. group Id
          BG002
          spread
          9.3
          value
          63.1
    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
          156
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          253
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          254
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          363
        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
          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
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        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
          11
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          387
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          582
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        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
          127
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          190
      title
      TPS <1%
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          388
      title
      TPS ≥1%
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          38
      title
      Not Evaluable
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from an archival or newly obtained biopsy. Participants with a TPS ≥1% were classified as PD-L1 positive and participants with a TPS \<1% were classified as PD-L1 negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          113
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          171
      title
      Cisplatin
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          445
      title
      Carboplatin
    description
    Participants were classified according to the type of platinum chemotherapy the Investigator chose for them to receive: Cisplatin or Carboplatin.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Platinum Chemotherapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          73
      title
      Never Smoker
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          362
        2. group Id
          BG001
          value
          181
        3. group Id
          BG002
          value
          543
      title
      Former/Current Smoker
    description
    Participants were classified according to their smoking status: Never Smoker or Former/Current Smoker.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Status
    unit Of Measure
    Participants
population Description
The Baseline Analysis Population consisted of all randomized participants.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice