TriangleNCT03037385 · OUTCOME
Phase 2: Intracranial ORR in RET-fusion Positive NSCLC Central Nervous System (CNS) Metastases Participants
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 79.8 months
What was measured
ORR=percentage of participants with CR or PR for at least 2 assessments with at least 28 days apart \& no PD in between. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem \&/or cerebellum identified at baseline \& disappearance of all non-target CNS/brain lesion at baseline \& no identification of new CNS/brain lesion. PR =at least a 30% decrease in the SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline \& if in the absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or the identification of new CNS/brain lesion. PD=either at least 20% increase in the SOD of target CNS/brain lesion, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of any CNS/brain lesion identified as RECIST 1.1 nontarget lesions at baseline, or the identification of new CNS/brain lesion.
Analysis population: RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As specified in the SAP, ORR was to be assessed in RET-fusion CNS metastases sub-population (participants with CNS metastases) only. Hence only NSCLC arms are presented here. Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis.
Groups in this outcome
RET- Fusion Positive NSCLC With Prior Platinum Treatment
Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-fusion Positive NSCLC With Non-platinum Systemic Treatment
Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment
Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
| Group | Source count |
|---|---|
| RET- Fusion Positive NSCLC With Prior Platinum Treatment | 13 |
| RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | 1 |
| RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RET- Fusion Positive NSCLC With Prior Platinum Treatment | 53.8 | Not reported | 25.1 | 80.8 | Not reported |
| RET-fusion Positive NSCLC With Non-platinum Systemic Treatment | 100 | Not reported | 2.5 | 100 | Not reported |
| RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment | 0 | Not reported | NA | NA | The 95% CI was not estimable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.1
- upper Limit
- 80.8
- value
- 53.8
- group Id
- OG001
- lower Limit
- 2.5
- upper Limit
- 100
- value
- 100
- comment
- The 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- ORR=percentage of participants with CR or PR for at least 2 assessments with at least 28 days apart \& no PD in between. CR=disappearance of all target CNS/brain lesion, including lesions in brain stem \&/or cerebellum identified at baseline \& disappearance of all non-target CNS/brain lesion at baseline \& no identification of new CNS/brain lesion. PR =at least a 30% decrease in the SOD of any CNS/brain lesion, identified as RECIST 1.1 target lesions at baseline \& if in the absence of unequivocal progression of any non-target CNS/brain lesion at baseline, or the identification of new CNS/brain lesion. PD=either at least 20% increase in the SOD of target CNS/brain lesion, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of any CNS/brain lesion identified as RECIST 1.1 nontarget lesions at baseline, or the identification of new CNS/brain lesion.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who had RET-fusion positive NSCLC previously treated with platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG000
- title
- RET- Fusion Positive NSCLC With Prior Platinum Treatment
- description
- Participants who had RET-fusion positive NSCLC previously treated with non-platinum or systemic therapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG001
- title
- RET-fusion Positive NSCLC With Non-platinum Systemic Treatment
- description
- Participants who had RET-fusion positive NSCLC not previously treated with systemic or platinum-based chemotherapies received pralsetinib, 400 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG002
- title
- RET-fusion Positive NSCLC With No Prior Systemic or Platinum Treatment
- param Type
- NUMBER
- population Description
- RET-altered measurable disease population included participants in the efficacy population who have measurable (target) disease per RECIST v1.1, at baseline according to BICR and sufficient evidence of a RET alteration. As specified in the SAP, ORR was to be assessed in RET-fusion CNS metastases sub-population (participants with CNS metastases) only. Hence only NSCLC arms are presented here. Phase 1 participants treated at 400 mg QD are pooled with Phase 2 participants for efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 79.8 months
- title
- Phase 2: Intracranial ORR in RET-fusion Positive NSCLC Central Nervous System (CNS) Metastases Participants
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice