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NCT03974022 · BASELINE

Baseline characteristics

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) · Source last updated 2026-01-29

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
      3
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      7
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      14
    8. group Id
      BG007
      value
      14
    9. group Id
      BG008
      value
      7
    10. group Id
      BG009
      value
      31
    11. group Id
      BG010
      value
      0
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
    id
    BG000
    title
    Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
  2. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
    id
    BG001
    title
    Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
  3. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
    id
    BG002
    title
    Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
  4. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
    id
    BG003
    title
    Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
  5. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
    id
    BG004
    title
    Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
  6. description
    Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
    id
    BG005
    title
    Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
  7. description
    Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
    id
    BG006
    title
    Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
  8. description
    Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
    id
    BG007
    title
    Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
  9. description
    Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
    id
    BG008
    title
    Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
  10. description
    Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
    id
    BG009
    title
    Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
  11. description
    Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
    id
    BG010
    title
    Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
  12. description
    Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
    id
    BG011
    title
    Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          72
          value
          48.0
        2. group Id
          BG001
          lower Limit
          48
          upper Limit
          83
          value
          62.0
        3. group Id
          BG002
          lower Limit
          55
          upper Limit
          74
          value
          57.0
        4. group Id
          BG003
          lower Limit
          57
          upper Limit
          82
          value
          64.0
        5. group Id
          BG004
          lower Limit
          48
          upper Limit
          85
          value
          63.5
        6. group Id
          BG005
          lower Limit
          41
          upper Limit
          83
          value
          61
        7. group Id
          BG006
          lower Limit
          41
          upper Limit
          76
          value
          62.5
        8. group Id
          BG007
          lower Limit
          34
          upper Limit
          73
          value
          60.5
        9. group Id
          BG008
          lower Limit
          38
          upper Limit
          73
          value
          64
        10. group Id
          BG009
          lower Limit
          37
          upper Limit
          96
          value
          61
        11. group Id
          BG011
          lower Limit
          39
          upper Limit
          82
          value
          44.0
        12. group Id
          BG012
          lower Limit
          55
          upper Limit
          78
          value
          65.0
    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
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          13
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          18
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          13
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          23
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          4
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      7
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      14
    8. group Id
      BG007
      value
      14
    9. group Id
      BG008
      value
      7
    10. group Id
      BG009
      value
      31
    11. group Id
      BG010
      value
      0
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
    id
    BG000
    title
    Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
  2. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
    id
    BG001
    title
    Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
  3. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
    id
    BG002
    title
    Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
  4. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
    id
    BG003
    title
    Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
  5. description
    Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
    id
    BG004
    title
    Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
  6. description
    Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
    id
    BG005
    title
    Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
  7. description
    Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
    id
    BG006
    title
    Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
  8. description
    Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
    id
    BG007
    title
    Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
  9. description
    Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
    id
    BG008
    title
    Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
  10. description
    Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
    id
    BG009
    title
    Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
  11. description
    Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
    id
    BG010
    title
    Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
  12. description
    Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
    id
    BG011
    title
    Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          72
          value
          48.0
        2. group Id
          BG001
          lower Limit
          48
          upper Limit
          83
          value
          62.0
        3. group Id
          BG002
          lower Limit
          55
          upper Limit
          74
          value
          57.0
        4. group Id
          BG003
          lower Limit
          57
          upper Limit
          82
          value
          64.0
        5. group Id
          BG004
          lower Limit
          48
          upper Limit
          85
          value
          63.5
        6. group Id
          BG005
          lower Limit
          41
          upper Limit
          83
          value
          61
        7. group Id
          BG006
          lower Limit
          41
          upper Limit
          76
          value
          62.5
        8. group Id
          BG007
          lower Limit
          34
          upper Limit
          73
          value
          60.5
        9. group Id
          BG008
          lower Limit
          38
          upper Limit
          73
          value
          64
        10. group Id
          BG009
          lower Limit
          37
          upper Limit
          96
          value
          61
        11. group Id
          BG011
          lower Limit
          39
          upper Limit
          82
          value
          44.0
        12. group Id
          BG012
          lower Limit
          55
          upper Limit
          78
          value
          65.0
    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
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          13
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          18
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          13
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          23
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          4
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.

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Preserved source evidence · Not medical advice