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NCT02546986 · BASELINE

Baseline characteristics

Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-07-22

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
      51
    2. group Id
      BG001
      value
      49
    3. group Id
      BG002
      value
      100
    units
    Participants
groups
  1. description
    Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
    id
    BG000
    title
    CC-486 and Pembrolizumab (CC-486 + PBZ)
  2. description
    Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
    id
    BG001
    title
    Placebo and Pembrolizumab (PBO + PBZ)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.03
          value
          62.8
        2. group Id
          BG001
          spread
          9.89
          value
          64.9
        3. group Id
          BG002
          spread
          9.96
          value
          63.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Intent-to-Treat population includes all participants who were randomized.
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          43
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          57
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Intent-to-Treat population includes all participants who were randomized.
    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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          87
        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
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Intent-to-Treat population includes all participants who were randomized.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          32
        title
        0 = Fully Active
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          68
        title
        1 = Restrictive but ambulatory
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        2 = ambulatory but unable to work
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        3 = limited self-care
    description
    ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant, and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        title
        Stage IIIA
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        Stage IIIB
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          70
        title
        Stage IV
    description
    Disease Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage at Primary Diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        title
        Squamous cell carcinoma
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          74
        title
        Adenocarcinoma
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
        title
        Other
    description
    The different types of lung cancer are described histologically by the types of cells the pathologist sees under the microscope. There are three major types of non-small cell lung cancer: Adenocarcinoma Squamous cell lung cancer (also called epidermoid carcinoma) Large cell lung cancer (Other)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.33
          value
          3.1
        2. group Id
          BG001
          spread
          1.25
          value
          2.8
        3. group Id
          BG002
          spread
          1.29
          value
          3.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Number of Metastatic Sites
    unit Of Measure
    Metastatic sites
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          18
      title
      Squamous Cell Carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          82
      title
      Non-Squamous Cell Carcinoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants Randomized by Strata
    unit Of Measure
    Participants
population Description
The Intent-to-Treat (ITT) population includes all participants who were randomized, regardless of whether they received assigned treatment or not
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      51
    2. group Id
      BG001
      value
      49
    3. group Id
      BG002
      value
      100
    units
    Participants
groups
  1. description
    Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
    id
    BG000
    title
    CC-486 and Pembrolizumab (CC-486 + PBZ)
  2. description
    Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
    id
    BG001
    title
    Placebo and Pembrolizumab (PBO + PBZ)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.03
          value
          62.8
        2. group Id
          BG001
          spread
          9.89
          value
          64.9
        3. group Id
          BG002
          spread
          9.96
          value
          63.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Intent-to-Treat population includes all participants who were randomized.
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          43
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          57
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Intent-to-Treat population includes all participants who were randomized.
    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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          87
        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
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Intent-to-Treat population includes all participants who were randomized.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          32
        title
        0 = Fully Active
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          68
        title
        1 = Restrictive but ambulatory
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        2 = ambulatory but unable to work
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        3 = limited self-care
    description
    ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant, and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        title
        Stage IIIA
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        Stage IIIB
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          70
        title
        Stage IV
    description
    Disease Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage at Primary Diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        title
        Squamous cell carcinoma
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          74
        title
        Adenocarcinoma
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
        title
        Other
    description
    The different types of lung cancer are described histologically by the types of cells the pathologist sees under the microscope. There are three major types of non-small cell lung cancer: Adenocarcinoma Squamous cell lung cancer (also called epidermoid carcinoma) Large cell lung cancer (Other)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.33
          value
          3.1
        2. group Id
          BG001
          spread
          1.25
          value
          2.8
        3. group Id
          BG002
          spread
          1.29
          value
          3.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Number of Metastatic Sites
    unit Of Measure
    Metastatic sites
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          18
      title
      Squamous Cell Carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          82
      title
      Non-Squamous Cell Carcinoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants Randomized by Strata
    unit Of Measure
    Participants
population Description
The Intent-to-Treat (ITT) population includes all participants who were randomized, regardless of whether they received assigned treatment or not

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