Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03915951 · BASELINE

Baseline characteristics

An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer · Source last updated 2026-03-24

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
      59
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      98
    units
    Participants
groups
  1. description
    Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
    id
    BG000
    title
    Treatment-Naive
  2. description
    Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
    id
    BG001
    title
    Previously Treated
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47
          upper Limit
          83
          value
          68
        2. group Id
          BG001
          lower Limit
          53
          upper Limit
          86
          value
          71
        3. group Id
          BG002
          lower Limit
          47
          upper Limit
          86
          value
          69.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          52
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          46
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        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
          2
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          86
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          19
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          26
      title
      Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          72
      title
      Grade 1
    description
    ECOG Performance Status Scoring: Grade 0: Fully active, able to carry on all predisease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours; Grade 3: capable of only limited self-care; confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair; Grade 5: dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperation Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
      title
      Current Smoking
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          56
      title
      Former Smoking
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          29
      title
      Never Smoking
    description
    Smoking history was collected at Screening by the Investigator or qualified designee.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Status
    unit Of Measure
    Participants
population Description
Baseline analysis population included all participants taking at least 1 dose of study intervention.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      59
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      98
    units
    Participants
groups
  1. description
    Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
    id
    BG000
    title
    Treatment-Naive
  2. description
    Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
    id
    BG001
    title
    Previously Treated
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47
          upper Limit
          83
          value
          68
        2. group Id
          BG001
          lower Limit
          53
          upper Limit
          86
          value
          71
        3. group Id
          BG002
          lower Limit
          47
          upper Limit
          86
          value
          69.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          52
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          46
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        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
          2
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          86
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          19
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          26
      title
      Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          72
      title
      Grade 1
    description
    ECOG Performance Status Scoring: Grade 0: Fully active, able to carry on all predisease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours; Grade 3: capable of only limited self-care; confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair; Grade 5: dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperation Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
      title
      Current Smoking
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          56
      title
      Former Smoking
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          29
      title
      Never Smoking
    description
    Smoking history was collected at Screening by the Investigator or qualified designee.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Status
    unit Of Measure
    Participants
population Description
Baseline analysis population included all participants taking at least 1 dose of study intervention.

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

Preserved source evidence · Not medical advice