TriangleNCT03974022 · OUTCOME
Part A: Confirmed ORR and DCR by Investigator.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.
What was measured
To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. Confirmed ORR was defined as the percentage of patients achieving a CR (Complete Response) or PR (Partial Response) and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by a subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.
Analysis population: Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.
Groups in this outcome
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
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.
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
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 sunvozertinib 100 mg once daily continuously.
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
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 sunvozertinib 200 mg once daily continuously.
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
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 sunvozertinib 300 mg once daily continuously.
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
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 sunvozertinib 400 mg once daily continuously.
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
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.
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
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.
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
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.
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
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.
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
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.
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
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 Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
| Group | Source count |
|---|---|
| Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg | 3 |
| Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg | 6 |
| Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg | 3 |
| Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg | 7 |
| Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg | 5 |
| Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State | 10 |
| Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State | 13 |
| Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal | 14 |
| Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal | 5 |
| Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal | 29 |
| Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg | 0 |
| Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted | 5 |
| Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal | 7 |
Reported measurements
Confirmed objective response rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg | 0 | Not reported | 0.0 | 70.8 | Not reported |
| Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg | 0 | Not reported | 0.0 | 70.8 | Not reported |
| Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg | 42.9 | Not reported | 9.9 | 81.6 | Not reported |
| Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg | 0 | Not reported | 0.0 | 52.2 | Not reported |
| Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State | 50 | Not reported | 18.7 | 81.3 | Not reported |
| Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State | 30.8 | Not reported | 9.1 | 61.4 | Not reported |
| Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal | 21.4 | Not reported | 4.7 | 50.8 | Not reported |
| Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal | 40.0 | Not reported | 5.3 | 85.3 | Not reported |
| Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal | 55.2 | Not reported | 35.7 | 73.6 | Not reported |
| Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
| Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal | 14.3 | Not reported | 0.4 | 57.9 | Not reported |
Confirmed disease control rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg | 100.0 | Not reported | 29.2 | 100.0 | Not reported |
| Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg | 50.0 | Not reported | 11.8 | 88.2 | Not reported |
| Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg | 66.7 | Not reported | 9.4 | 99.2 | Not reported |
| Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg | 71.4 | Not reported | 29.0 | 96.3 | Not reported |
| Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg | 60.0 | Not reported | 14.7 | 94.7 | Not reported |
| Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State | 80 | Not reported | 44.4 | 97.5 | Not reported |
| Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State | 84.6 | Not reported | 54.6 | 98.1 | Not reported |
| Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal | 92.9 | Not reported | 66.1 | 99.8 | Not reported |
| Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal | 80.0 | Not reported | 28.4 | 99.5 | Not reported |
| Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal | 93.1 | Not reported | 77.2 | 99.2 | Not reported |
| Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted | 60.0 | Not reported | 14.7 | 94.7 | Not reported |
| Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal | 85.7 | Not reported | 42.1 | 99.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0
- group Id
- OG003
- lower Limit
- 9.9
- upper Limit
- 81.6
- value
- 42.9
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0
- group Id
- OG005
- lower Limit
- 18.7
- upper Limit
- 81.3
- value
- 50
- group Id
- OG006
- lower Limit
- 9.1
- upper Limit
- 61.4
- value
- 30.8
- group Id
- OG007
- lower Limit
- 4.7
- upper Limit
- 50.8
- value
- 21.4
- group Id
- OG008
- lower Limit
- 5.3
- upper Limit
- 85.3
- value
- 40.0
- group Id
- OG009
- lower Limit
- 35.7
- upper Limit
- 73.6
- value
- 55.2
- group Id
- OG011
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG012
- lower Limit
- 0.4
- upper Limit
- 57.9
- value
- 14.3
- title
- Confirmed objective response rate
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.2
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG001
- lower Limit
- 11.8
- upper Limit
- 88.2
- value
- 50.0
- group Id
- OG002
- lower Limit
- 9.4
- upper Limit
- 99.2
- value
- 66.7
- group Id
- OG003
- lower Limit
- 29.0
- upper Limit
- 96.3
- value
- 71.4
- group Id
- OG004
- lower Limit
- 14.7
- upper Limit
- 94.7
- value
- 60.0
- group Id
- OG005
- lower Limit
- 44.4
- upper Limit
- 97.5
- value
- 80
- group Id
- OG006
- lower Limit
- 54.6
- upper Limit
- 98.1
- value
- 84.6
- group Id
- OG007
- lower Limit
- 66.1
- upper Limit
- 99.8
- value
- 92.9
- group Id
- OG008
- lower Limit
- 28.4
- upper Limit
- 99.5
- value
- 80.0
- group Id
- OG009
- lower Limit
- 77.2
- upper Limit
- 99.2
- value
- 93.1
- group Id
- OG011
- lower Limit
- 14.7
- upper Limit
- 94.7
- value
- 60.0
- group Id
- OG012
- lower Limit
- 42.1
- upper Limit
- 99.6
- value
- 85.7
- title
- Confirmed disease control rate
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 29
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. Confirmed ORR was defined as the percentage of patients achieving a CR (Complete Response) or PR (Partial Response) and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by a subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.
- dispersion Type
- 95% Confidence Interval
- 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
- OG000
- 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 sunvozertinib 100 mg once daily continuously.
- id
- OG001
- 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 sunvozertinib 200 mg once daily continuously.
- id
- OG002
- 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 sunvozertinib 300 mg once daily continuously.
- id
- OG003
- 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 sunvozertinib 400 mg once daily continuously.
- id
- OG004
- 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
- OG005
- 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
- OG006
- 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
- OG007
- 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
- OG008
- 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
- OG009
- 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
- OG010
- 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
- OG011
- title
- Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
- param Type
- NUMBER
- population Description
- Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.
- reporting Status
- POSTED
- time Frame
- The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.
- title
- Part A: Confirmed ORR and DCR by Investigator.
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice