TriangleNCT04194944 · OUTCOME
Median Intracranial DOR Per RECIST 1.1 by BICR (With Pembrolizumab)
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
- Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
What was measured
Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)
Analysis population: CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 13; TRT B: 9.
Groups in this outcome
Selpercatinib (TRT A)
160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
Pemetrexed and Platinum With Pembrolizumab (TRT B)
Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin AUC 5 (maximum dose 750 mg) IV or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
| Group | Source count |
|---|---|
| Selpercatinib (TRT A) | 17 |
| Pemetrexed and Platinum With Pembrolizumab (TRT B) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Selpercatinib (TRT A) | NA | Not reported | 14.75 | NA | Median and upper limit of 95% Confidence Interval unavailable due to high censoring. |
| Pemetrexed and Platinum With Pembrolizumab (TRT B) | NA | Not reported | 8.74 | NA | Median and upper limit of 95% Confidence Interval unavailable due to high censoring. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% Confidence Interval unavailable due to high censoring.
- group Id
- OG000
- lower Limit
- 14.75
- upper Limit
- NA
- value
- NA
- comment
- Median and upper limit of 95% Confidence Interval unavailable due to high censoring.
- group Id
- OG001
- lower Limit
- 8.74
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
- id
- OG000
- title
- Selpercatinib (TRT A)
- description
- Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin AUC 5 (maximum dose 750 mg) IV or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
- id
- OG001
- title
- Pemetrexed and Platinum With Pembrolizumab (TRT B)
- param Type
- MEDIAN
- population Description
- CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 13; TRT B: 9.
- reporting Status
- POSTED
- time Frame
- Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
- title
- Median Intracranial DOR Per RECIST 1.1 by BICR (With Pembrolizumab)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice