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NCT04303780 · BASELINE

Baseline characteristics

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). · 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
      171
    2. group Id
      BG001
      value
      174
    3. group Id
      BG002
      value
      345
    units
    Participants
groups
  1. description
    Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle.
    id
    BG000
    title
    AMG 510
  2. description
    Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
    id
    BG001
    title
    Docetaxel
  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
          63.4
        2. group Id
          BG001
          spread
          9.1
          value
          63.6
        3. group Id
          BG002
          spread
          9.5
          value
          63.5
    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
          62
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          141
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          204
        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
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          328
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
          21
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          43
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          142
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          286
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
As pre-specified in the statistical analysis plan, data are presented for all randomized participants according to original treatment assignment, regardless of whether participants switched from receiving docetaxel to receiving AMG 510.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      171
    2. group Id
      BG001
      value
      174
    3. group Id
      BG002
      value
      345
    units
    Participants
groups
  1. description
    Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 960 mg of AMG 510 orally via tablets QD in each 21 day cycle.
    id
    BG000
    title
    AMG 510
  2. description
    Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
    id
    BG001
    title
    Docetaxel
  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
          63.4
        2. group Id
          BG001
          spread
          9.1
          value
          63.6
        3. group Id
          BG002
          spread
          9.5
          value
          63.5
    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
          62
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          141
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          204
        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
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          328
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
          21
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          43
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          142
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          286
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
As pre-specified in the statistical analysis plan, data are presented for all randomized participants according to original treatment assignment, regardless of whether participants switched from receiving docetaxel to receiving AMG 510.

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

Preserved source evidence · Not medical advice