NCT04194944 · OUTCOME
Median Time to CNS Progression 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
- Baseline through CNS Progression or Death Up to 31 Months
What was measured
Time to CNS Progression 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. Number of participants censored: TRT A = 112; TRT B = 59.
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) | 120 |
| Pemetrexed and Platinum With Pembrolizumab (TRT B) | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Selpercatinib (TRT A) | NA | Not reported | NA | NA | Data not available due to high censoring. |
| Pemetrexed and Platinum With Pembrolizumab (TRT B) | NA | Not reported | NA | NA | Data not available due to high censoring. |
Complete source fields
- classes
- categories
- measurements
- comment
- Data not available due to high censoring.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Data not available due to high censoring.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 72
- units
- Participants
- description
- Time to CNS Progression 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. Number of participants censored: TRT A = 112; TRT B = 59.
- reporting Status
- POSTED
- time Frame
- Baseline through CNS Progression or Death Up to 31 Months
- title
- Median Time to CNS Progression 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
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