NCT04194944 · OUTCOME
PFS2 (With or Without 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 to Second Disease Progression or Death from Any Cause Up to 38 Months
What was measured
PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression.
Analysis population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 126; TRT B: 77
Groups in this outcome
Selpercatinib (TRT A)
160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
Pemetrexed and Platinum With or Without 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 or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
| Group | Source count |
|---|---|
| Selpercatinib (TRT A) | 159 |
| Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) | 102 |
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 or Without 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
- 159
- group Id
- OG001
- value
- 102
- units
- Participants
- description
- PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression.
- 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 or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
- id
- OG001
- title
- Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)
- param Type
- MEDIAN
- population Description
- ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 126; TRT B: 77
- reporting Status
- POSTED
- time Frame
- Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
- title
- PFS2 (With or Without 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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