NCT03974022 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- 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 sunvozertinib 50 mg once daily continuously.
- id
- FG000
- title
- Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
- 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
- FG001
- title
- Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
- 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
- FG002
- title
- Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
- 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
- FG003
- title
- Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
- 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
- FG004
- title
- Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
- 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
- FG005
- title
- Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
- 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
- FG006
- title
- Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
- 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
- FG007
- title
- Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
- 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
- FG008
- title
- Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
- id
- FG009
- title
- Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
- id
- FG010
- title
- Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
- 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
- FG011
- title
- Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 2
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 2
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 4
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 4
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 2
- group Id
- FG008
- num Subjects
- 2
- group Id
- FG009
- num Subjects
- 3
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- site terminated by sponsor or non compliance
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 6
- group Id
- FG005
- num Subjects
- 10
- group Id
- FG006
- num Subjects
- 14
- group Id
- FG007
- num Subjects
- 14
- group Id
- FG008
- num Subjects
- 7
- group Id
- FG009
- num Subjects
- 31
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 5
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 5
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 5
- group Id
- FG006
- num Subjects
- 8
- group Id
- FG007
- num Subjects
- 10
- group Id
- FG008
- num Subjects
- 3
- group Id
- FG009
- num Subjects
- 24
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 4
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 2
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 5
- group Id
- FG006
- num Subjects
- 6
- group Id
- FG007
- num Subjects
- 4
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 7
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- 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 sunvozertinib 50 mg once daily continuously.
- id
- FG000
- title
- Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
- 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
- FG001
- title
- Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
- 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
- FG002
- title
- Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
- 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
- FG003
- title
- Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
- 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
- FG004
- title
- Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
- 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
- FG005
- title
- Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
- 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
- FG006
- title
- Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
- 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
- FG007
- title
- Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
- 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
- FG008
- title
- Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
- id
- FG009
- title
- Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
- id
- FG010
- title
- Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
- 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
- FG011
- title
- Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 2
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 2
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 4
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 4
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 2
- group Id
- FG008
- num Subjects
- 2
- group Id
- FG009
- num Subjects
- 3
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- site terminated by sponsor or non compliance
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 6
- group Id
- FG005
- num Subjects
- 10
- group Id
- FG006
- num Subjects
- 14
- group Id
- FG007
- num Subjects
- 14
- group Id
- FG008
- num Subjects
- 7
- group Id
- FG009
- num Subjects
- 31
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 5
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 5
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 5
- group Id
- FG006
- num Subjects
- 8
- group Id
- FG007
- num Subjects
- 10
- group Id
- FG008
- num Subjects
- 3
- group Id
- FG009
- num Subjects
- 24
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 4
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 2
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 5
- group Id
- FG006
- num Subjects
- 6
- group Id
- FG007
- num Subjects
- 4
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 7
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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