Skip to content
← Full study record

NCT02414139 · OUTCOME

All Collected Deaths

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1) · Source last updated 2024-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
On-treatment: Up to approximately 5.5 years. Post-treatment efficacy/survival follow-up: Up to approximately 6 years

What was measured

On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment. Post-treatment efficacy/survival follow-up deaths were collected from 31 days after last dose of treatment until the end of the study. All deaths refer to the sum of on-treatment and post-treatment efficacy/survival follow-up deaths.

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)

All Participants

All participants

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource 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
All Participants373

Reported measurements

On-treatment

Analysis denominator · Participants

GroupSource 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
All Participants373
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)10Not reportedNot reportedNot reportedNot reported
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)7Not reportedNot reportedNot reportedNot reported
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)12Not reportedNot reportedNot reportedNot reported
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)4Not reportedNot reportedNot reportedNot reported
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)14Not reportedNot reportedNot reportedNot reported
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)0Not reportedNot reportedNot reportedNot reported
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)5Not reportedNot reportedNot reportedNot reported
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)1Not reportedNot reportedNot reportedNot reported
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)5Not reportedNot reportedNot reportedNot reported
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)5Not reportedNot reportedNot reportedNot reported
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)19Not reportedNot reportedNot reportedNot reported
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)10Not reportedNot reportedNot reportedNot reported
All Participants63Not reportedNot reportedNot reportedNot reported
Post-treatment efficacy/survival follow-up

Analysis denominator · Participants

GroupSource count
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)59
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)35
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)42
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)25
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)55
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)15
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)20
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)2
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)20
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)23
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)75
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)43
All Participants296
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)44Not reportedNot reportedNot reportedNot reported
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)26Not reportedNot reportedNot reportedNot reported
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)34Not reportedNot reportedNot reportedNot reported
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)22Not reportedNot reportedNot reportedNot reported
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)44Not reportedNot reportedNot reportedNot reported
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)13Not reportedNot reportedNot reportedNot reported
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)13Not reportedNot reportedNot reportedNot reported
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)2Not reportedNot reportedNot reportedNot reported
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)17Not reportedNot reportedNot reportedNot reported
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)16Not reportedNot reportedNot reportedNot reported
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)61Not reportedNot reportedNot reportedNot reported
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)29Not reportedNot reportedNot reportedNot reported
All Participants231Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource 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
All Participants373
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)54Not reportedNot reportedNot reportedNot reported
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)33Not reportedNot reportedNot reportedNot reported
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)46Not reportedNot reportedNot reportedNot reported
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)26Not reportedNot reportedNot reportedNot reported
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)58Not reportedNot reportedNot reportedNot reported
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)13Not reportedNot reportedNot reportedNot reported
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)18Not reportedNot reportedNot reportedNot reported
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)3Not reportedNot reportedNot reportedNot reported
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)22Not reportedNot reportedNot reportedNot reported
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)21Not reportedNot reportedNot reportedNot reported
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)80Not reportedNot reportedNot reportedNot reported
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)39Not reportedNot reportedNot reportedNot reported
All Participants294Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        14
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        5
      11. group Id
        OG010
        value
        19
      12. group Id
        OG011
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        42
      3. group Id
        OG002
        value
        54
      4. group Id
        OG003
        value
        30
      5. group Id
        OG004
        value
        69
      6. group Id
        OG005
        value
        15
      7. group Id
        OG006
        value
        28
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        31
      10. group Id
        OG009
        value
        32
      11. group Id
        OG010
        value
        100
      12. group Id
        OG011
        value
        60
      units
      Participants
    title
    On-treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        34
      4. group Id
        OG003
        value
        22
      5. group Id
        OG004
        value
        44
      6. group Id
        OG005
        value
        13
      7. group Id
        OG006
        value
        13
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        17
      10. group Id
        OG009
        value
        16
      11. group Id
        OG010
        value
        61
      12. group Id
        OG011
        value
        29
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        35
      3. group Id
        OG002
        value
        42
      4. group Id
        OG003
        value
        25
      5. group Id
        OG004
        value
        55
      6. group Id
        OG005
        value
        15
      7. group Id
        OG006
        value
        20
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        20
      10. group Id
        OG009
        value
        23
      11. group Id
        OG010
        value
        75
      12. group Id
        OG011
        value
        43
      units
      Participants
    title
    Post-treatment efficacy/survival follow-up
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        46
      4. group Id
        OG003
        value
        26
      5. group Id
        OG004
        value
        58
      6. group Id
        OG005
        value
        13
      7. group Id
        OG006
        value
        18
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        22
      10. group Id
        OG009
        value
        21
      11. group Id
        OG010
        value
        80
      12. group Id
        OG011
        value
        39
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        42
      3. group Id
        OG002
        value
        54
      4. group Id
        OG003
        value
        30
      5. group Id
        OG004
        value
        69
      6. group Id
        OG005
        value
        15
      7. group Id
        OG006
        value
        28
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        31
      10. group Id
        OG009
        value
        32
      11. group Id
        OG010
        value
        100
      12. group Id
        OG011
        value
        60
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      42
    3. group Id
      OG002
      value
      54
    4. group Id
      OG003
      value
      30
    5. group Id
      OG004
      value
      69
    6. group Id
      OG005
      value
      15
    7. group Id
      OG006
      value
      28
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      31
    10. group Id
      OG009
      value
      32
    11. group Id
      OG010
      value
      100
    12. group Id
      OG011
      value
      60
    units
    Participants
description
On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment. Post-treatment efficacy/survival follow-up deaths were collected from 31 days after last dose of treatment until the end of the study. All deaths refer to the sum of on-treatment and post-treatment efficacy/survival follow-up deaths.
groups
  1. 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)
  2. 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)
  3. 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)
  4. 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)
  5. 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)
  6. 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)
  7. 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)
  8. 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)
  9. 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)
  10. 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)
  11. 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)
  12. 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
NUMBER
population Description
FAS, including all subjects who received at least one dose of capmatinib
reporting Status
POSTED
time Frame
On-treatment: Up to approximately 5.5 years. Post-treatment efficacy/survival follow-up: Up to approximately 6 years
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice