NCT03974022 · OUTCOME
Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR 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
- NUMBER
- Unit
- percentage of participants
- 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 at a 1:1 ratio 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 at a 1:1 ratio 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
confirmed DCR by IRC
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 89.4 | Not reported | 80.8 | 95.0 | Not reported |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 88.8 | Not reported | 81.2 | 94.1 | Not reported |
confirmed DCR by investigator
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 88.2 | Not reported | 79.4 | 94.2 | Not reported |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 88.8 | Not reported | 81.2 | 94.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 80.8
- upper Limit
- 95.0
- value
- 89.4
- group Id
- OG001
- lower Limit
- 81.2
- upper Limit
- 94.1
- value
- 88.8
- title
- confirmed DCR by IRC
- categories
- measurements
- group Id
- OG000
- lower Limit
- 79.4
- upper Limit
- 94.2
- value
- 88.2
- group Id
- OG001
- lower Limit
- 81.2
- upper Limit
- 94.1
- value
- 88.8
- title
- confirmed DCR by 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 at a 1:1 ratio 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 at a 1:1 ratio 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
- NUMBER
- reporting Status
- POSTED
- time Frame
- Through the study completion, an average of around 1 year for part B
- title
- Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR Using Investigators Assessments According to RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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