TriangleNCT04222972 · OUTCOME
Arm A vs Arm B: Objective Response Rate (ORR)
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
- Up to approximately 50 months
What was measured
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off.
Analysis population: ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
Groups in this outcome
Arm A: Treatment Period- SOC
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
Arm B: Treatment Period- Pralsetinib
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
| Group | Source count |
|---|---|
| Arm A: Treatment Period- SOC | 113 |
| Arm B: Treatment Period- Pralsetinib | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Treatment Period- SOC | 41.6 | Not reported | 32.40 | 51.24 | Not reported |
| Arm B: Treatment Period- Pralsetinib | 65.5 | Not reported | 55.79 | 74.26 | Not reported |
Source statistical analyses
- ci Lower Limit
- 10.25
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 37.47
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- param Type
- Difference in Overall Response Rates
- param Value
- 23.86
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 10.25
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 37.47
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- param Type
- Difference in Overall Response Rates
- param Value
- 23.86
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.40
- upper Limit
- 51.24
- value
- 41.6
- group Id
- OG001
- lower Limit
- 55.79
- upper Limit
- 74.26
- value
- 65.5
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
- id
- OG000
- title
- Arm A: Treatment Period- SOC
- description
- Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
- id
- OG001
- title
- Arm B: Treatment Period- Pralsetinib
- param Type
- NUMBER
- population Description
- ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
- reporting Status
- POSTED
- time Frame
- Up to approximately 50 months
- title
- Arm A vs Arm B: Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice