TriangleNCT03974022 · OUTCOME
Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Through the study completion, an average of around 1 year for part B
What was measured
To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
Groups in this outcome
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
| Group | Source count |
|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 85 |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 107 |
Reported measurements
Median duration of response (IRC)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | NA | Not reported | 7.2 | NA | NA means Not Estimable due to data not mature (lack of events observed being lower than 50%) |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | NA | Not reported | 6.7 | NA | NA means Not Estimable due to data not mature (lack of events observed being lower than 50%) |
Median duration of response (investigator)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 8.3 | Not reported | 7.0 | NA | NA means Not Estimable due to data not mature (lack of events observed being lower than 50%) |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 8.8 | Not reported | 5.3 | 18.0 | Not reported |
Median progression free survival (IRC)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 8.4 | Not reported | 6.8 | 11.2 | Not reported |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 6.9 | Not reported | 5.6 | 11.0 | Not reported |
Median progression free survival (investigator)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 8.3 | Not reported | 5.5 | 10.9 | Not reported |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 6.8 | Not reported | 5.5 | 8.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA means Not Estimable due to data not mature (lack of events observed being lower than 50%)
- group Id
- OG000
- lower Limit
- 7.2
- upper Limit
- NA
- value
- NA
- comment
- NA means Not Estimable due to data not mature (lack of events observed being lower than 50%)
- group Id
- OG001
- lower Limit
- 6.7
- upper Limit
- NA
- value
- NA
- title
- Median duration of response (IRC)
- categories
- measurements
- comment
- NA means Not Estimable due to data not mature (lack of events observed being lower than 50%)
- group Id
- OG000
- lower Limit
- 7.0
- upper Limit
- NA
- value
- 8.3
- group Id
- OG001
- lower Limit
- 5.3
- upper Limit
- 18.0
- value
- 8.8
- title
- Median duration of response (investigator)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.8
- upper Limit
- 11.2
- value
- 8.4
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 11.0
- value
- 6.9
- title
- Median progression free survival (IRC)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 10.9
- value
- 8.3
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- 8.3
- value
- 6.8
- title
- Median progression free survival (investigator)
- denoms
- counts
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
- id
- OG000
- title
- Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
- id
- OG001
- title
- Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Through the study completion, an average of around 1 year for part B
- title
- Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice