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NCT02414139 · OUTCOME

Time to Response (TTR) by BIRC Assessment

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
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Up to approximately 5 years

What was measured

Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by BIRC assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Analysis population: Participants with confirmed CR or PR by BIRC in FAS

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 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)20
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)5
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)5
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)2
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)28
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)6
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)19
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)0
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)16
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)22
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)44
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)41

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)1.4Not reported0.56.8Not reported
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)2.8Not reported1.416.6Not reported
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)1.4Not reported1.26.2Not reported
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)3.4Not reported1.35.5Not reported
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)1.4Not reported1.25.6Not reported
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)1.4Not reported1.22.9Not reported
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)1.4Not reported1.36.9Not reported
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)1.4Not reported1.19.8Not reported
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)1.4Not reported1.27.2Not reported
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)1.4Not reported1.19.8Not reported
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)1.4Not reported1.27.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        6.8
        value
        1.4
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        16.6
        value
        2.8
      3. group Id
        OG002
        lower Limit
        1.2
        upper Limit
        6.2
        value
        1.4
      4. group Id
        OG003
        lower Limit
        1.3
        upper Limit
        5.5
        value
        3.4
      5. group Id
        OG004
        lower Limit
        1.2
        upper Limit
        5.6
        value
        1.4
      6. group Id
        OG005
        lower Limit
        1.2
        upper Limit
        2.9
        value
        1.4
      7. group Id
        OG006
        lower Limit
        1.3
        upper Limit
        6.9
        value
        1.4
      8. group Id
        OG008
        lower Limit
        1.1
        upper Limit
        9.8
        value
        1.4
      9. group Id
        OG009
        lower Limit
        1.2
        upper Limit
        7.2
        value
        1.4
      10. group Id
        OG010
        lower Limit
        1.1
        upper Limit
        9.8
        value
        1.4
      11. group Id
        OG011
        lower Limit
        1.2
        upper Limit
        7.2
        value
        1.4
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      28
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      19
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      16
    10. group Id
      OG009
      value
      22
    11. group Id
      OG010
      value
      44
    12. group Id
      OG011
      value
      41
    units
    Participants
description
Time between date of start of treatment until first documented response (confirmed CR or PR) per RECIST 1.1 by BIRC assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
dispersion Type
Full Range
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
MEDIAN
population Description
Participants with confirmed CR or PR by BIRC in FAS
reporting Status
POSTED
time Frame
Up to approximately 5 years
title
Time to Response (TTR) by BIRC Assessment
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice