TriangleNCT02414139 · OUTCOME
Progression-Free Survival
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
- Up to approximately 5 years
What was measured
Time from start of treatment to the date of the first documented progression or death due to any cause per RECIST 1.1 by BIRC and investigator assessment. Clinical deterioration was not considered as a qualifying event for progression. PFS was censored at the last adequate tumor assessment if one of the following occurred: absence of event or the event occurred after two or more missing tumor assessments. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported. Progressive disease: For target lesions, at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. For non-target lesions, unequivocal progression of existing non-target lesions
Analysis population: FAS, including all subjects who received at least one dose of capmatinib.
Groups in this outcome
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
| Group | Source count |
|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 69 |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 42 |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 54 |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 30 |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 69 |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 15 |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 28 |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 3 |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 31 |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 32 |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 100 |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 60 |
Reported measurements
By BIRC assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 4.07 | Not reported | 2.86 | 4.83 | Not reported |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 2.66 | Not reported | 1.41 | 3.09 | Not reported |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 2.66 | Not reported | 1.41 | 4.14 | Not reported |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 3.55 | Not reported | 2.20 | 4.21 | Not reported |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 5.42 | Not reported | 4.17 | 6.97 | Not reported |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 4.17 | Not reported | 1.45 | 6.87 | Not reported |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 12.42 | Not reported | 8.21 | 23.39 | Not reported |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 2.79 | Not reported | 2.07 | 4.24 | Not reported |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 6.93 | Not reported | 4.17 | 13.34 | Not reported |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 12.45 | Not reported | 6.87 | 22.05 | Not reported |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 5.49 | Not reported | 4.17 | 8.11 | Not reported |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 12.45 | Not reported | 8.31 | 17.97 | Not reported |
By investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 4.14 | Not reported | 2.79 | 5.52 | Not reported |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 2.40 | Not reported | 1.45 | 2.83 | Not reported |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 2.60 | Not reported | 1.48 | 3.09 | Not reported |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 2.73 | Not reported | 1.45 | 3.78 | Not reported |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 4.80 | Not reported | 4.11 | 7.75 | Not reported |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 2.76 | Not reported | 1.45 | 6.87 | Not reported |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 11.99 | Not reported | 5.52 | 16.92 | Not reported |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 2.76 | Not reported | 2.07 | 2.79 | Not reported |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 6.90 | Not reported | 5.55 | 17.31 | Not reported |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 9.79 | Not reported | 5.75 | 16.36 | Not reported |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 6.60 | Not reported | 4.70 | 8.18 | Not reported |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 11.07 | Not reported | 6.87 | 15.18 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.86
- upper Limit
- 4.83
- value
- 4.07
- group Id
- OG001
- lower Limit
- 1.41
- upper Limit
- 3.09
- value
- 2.66
- group Id
- OG002
- lower Limit
- 1.41
- upper Limit
- 4.14
- value
- 2.66
- group Id
- OG003
- lower Limit
- 2.20
- upper Limit
- 4.21
- value
- 3.55
- group Id
- OG004
- lower Limit
- 4.17
- upper Limit
- 6.97
- value
- 5.42
- group Id
- OG005
- lower Limit
- 1.45
- upper Limit
- 6.87
- value
- 4.17
- group Id
- OG006
- lower Limit
- 8.21
- upper Limit
- 23.39
- value
- 12.42
- group Id
- OG007
- lower Limit
- 2.07
- upper Limit
- 4.24
- value
- 2.79
- group Id
- OG008
- lower Limit
- 4.17
- upper Limit
- 13.34
- value
- 6.93
- group Id
- OG009
- lower Limit
- 6.87
- upper Limit
- 22.05
- value
- 12.45
- group Id
- OG010
- lower Limit
- 4.17
- upper Limit
- 8.11
- value
- 5.49
- group Id
- OG011
- lower Limit
- 8.31
- upper Limit
- 17.97
- value
- 12.45
- title
- By BIRC assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.79
- upper Limit
- 5.52
- value
- 4.14
- group Id
- OG001
- lower Limit
- 1.45
- upper Limit
- 2.83
- value
- 2.40
- group Id
- OG002
- lower Limit
- 1.48
- upper Limit
- 3.09
- value
- 2.60
- group Id
- OG003
- lower Limit
- 1.45
- upper Limit
- 3.78
- value
- 2.73
- group Id
- OG004
- lower Limit
- 4.11
- upper Limit
- 7.75
- value
- 4.80
- group Id
- OG005
- lower Limit
- 1.45
- upper Limit
- 6.87
- value
- 2.76
- group Id
- OG006
- lower Limit
- 5.52
- upper Limit
- 16.92
- value
- 11.99
- group Id
- OG007
- lower Limit
- 2.07
- upper Limit
- 2.79
- value
- 2.76
- group Id
- OG008
- lower Limit
- 5.55
- upper Limit
- 17.31
- value
- 6.90
- group Id
- OG009
- lower Limit
- 5.75
- upper Limit
- 16.36
- value
- 9.79
- group Id
- OG010
- lower Limit
- 4.70
- upper Limit
- 8.18
- value
- 6.60
- group Id
- OG011
- lower Limit
- 6.87
- upper Limit
- 15.18
- value
- 11.07
- title
- By investigator assessment
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 54
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 69
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 28
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 31
- group Id
- OG009
- value
- 32
- group Id
- OG010
- value
- 100
- group Id
- OG011
- value
- 60
- units
- Participants
- description
- Time from start of treatment to the date of the first documented progression or death due to any cause per RECIST 1.1 by BIRC and investigator assessment. Clinical deterioration was not considered as a qualifying event for progression. PFS was censored at the last adequate tumor assessment if one of the following occurred: absence of event or the event occurred after two or more missing tumor assessments. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported. Progressive disease: For target lesions, at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. For non-target lesions, unequivocal progression of existing non-target lesions
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG000
- title
- Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
- description
- Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
- id
- OG001
- title
- Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
- description
- Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG002
- title
- Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
- description
- Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG003
- title
- Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
- description
- Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG004
- title
- Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
- description
- Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
- id
- OG005
- title
- Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
- description
- Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
- id
- OG006
- title
- Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
- description
- Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
- id
- OG007
- title
- Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
- description
- Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
- id
- OG008
- title
- Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
- description
- Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
- id
- OG009
- title
- Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
- description
- All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
- id
- OG010
- title
- Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
- description
- All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
- id
- OG011
- title
- Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
- param Type
- MEDIAN
- population Description
- FAS, including all subjects who received at least one dose of capmatinib.
- reporting Status
- POSTED
- time Frame
- Up to approximately 5 years
- title
- Progression-Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice