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NCT02411448 · BASELINE

Baseline characteristics

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) · Source last updated 2026-01-16

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
      14
    2. group Id
      BG001
      value
      224
    3. group Id
      BG002
      value
      225
    4. group Id
      BG003
      value
      463
    units
    Participants
groups
  1. description
    Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    BG000
    title
    Part A: Ramucirumab + Erlotinib
  2. description
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    BG001
    title
    Part B: Ramucirumab+ Erlotinib
  3. description
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    BG002
    title
    Part B: Placebo+ Erlotinib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.2
          value
          67.6
        2. comment
          Row represents Part A data only.
          group Id
          BG001
          spread
          NA
          value
          NA
        3. comment
          Row represents Part A data only.
          group Id
          BG002
          spread
          NA
          value
          NA
        4. group Id
          BG003
          spread
          13
          value
          67.6
      title
      Part A
    2. categories
      1. measurements
        1. comment
          Row represents Part B data only.
          group Id
          BG000
          spread
          NA
          value
          NA
        2. group Id
          BG001
          spread
          10.2
          value
          63.7
        3. group Id
          BG002
          spread
          10.6
          value
          62.9
        4. group Id
          BG003
          spread
          10.4
          value
          63.3
      title
      Part B
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          142
        4. group Id
          BG003
          value
          294
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          169
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          160
        4. group Id
          BG003
          value
          311
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          129
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          172
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          353
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          107
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Romania
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          15
      title
      Hong Kong
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          218
      title
      Japan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          49
      title
      Spain
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
      title
      Canada
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          54
      title
      South Korea
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
      title
      Turkey
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          56
      title
      Taiwan
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          20
      title
      Italy
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          11
      title
      France
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          166
        3. group Id
          BG002
          value
          170
        4. group Id
          BG003
          value
          343
      title
      East Asia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          120
      title
      Other*
    description
    \* Geographic region "Other" includes Canada, France, Germany, Italy, Romania, Spain, Turkey, US, UK.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
population Description
All enrolled participants. Part C data will be reported after study completion.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      14
    2. group Id
      BG001
      value
      224
    3. group Id
      BG002
      value
      225
    4. group Id
      BG003
      value
      463
    units
    Participants
groups
  1. description
    Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    BG000
    title
    Part A: Ramucirumab + Erlotinib
  2. description
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    BG001
    title
    Part B: Ramucirumab+ Erlotinib
  3. description
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    BG002
    title
    Part B: Placebo+ Erlotinib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.2
          value
          67.6
        2. comment
          Row represents Part A data only.
          group Id
          BG001
          spread
          NA
          value
          NA
        3. comment
          Row represents Part A data only.
          group Id
          BG002
          spread
          NA
          value
          NA
        4. group Id
          BG003
          spread
          13
          value
          67.6
      title
      Part A
    2. categories
      1. measurements
        1. comment
          Row represents Part B data only.
          group Id
          BG000
          spread
          NA
          value
          NA
        2. group Id
          BG001
          spread
          10.2
          value
          63.7
        3. group Id
          BG002
          spread
          10.6
          value
          62.9
        4. group Id
          BG003
          spread
          10.4
          value
          63.3
      title
      Part B
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          142
        4. group Id
          BG003
          value
          294
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          169
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          160
        4. group Id
          BG003
          value
          311
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          129
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          172
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          353
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          107
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Romania
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          15
      title
      Hong Kong
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          218
      title
      Japan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          49
      title
      Spain
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
      title
      Canada
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          54
      title
      South Korea
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
      title
      Turkey
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          56
      title
      Taiwan
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          20
      title
      Italy
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          11
      title
      France
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          166
        3. group Id
          BG002
          value
          170
        4. group Id
          BG003
          value
          343
      title
      East Asia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          120
      title
      Other*
    description
    \* Geographic region "Other" includes Canada, France, Germany, Italy, Romania, Spain, Turkey, US, UK.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
population Description
All enrolled participants. Part C data will be reported after study completion.

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