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← Emrelis: metastatic Non-small cell lung cancer with MET stated without a specific alteration after prior therapy

NCT02864992 · STUDY IN CONTEXT

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Draft scope assessment: unclear. Attached because the study's own record names MET and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Safty Analysis Set included all participants in Cohort A who were administered at least 1 dose of tepotinib, including participants with METex14 skipping alterations not confirmed by a validated central laboratory assay.

→

primary · POSTED

Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Safety Analysis Set included all participants in Cohort B who were administered at least 1 dose of tepotinib, including participants with a MET Amplification.

→

primary · POSTED

Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Safety analysis set included all participants in Cohort C who were administered at least 1 dose of tepotinib.

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secondary · NOT_POSTED

Part 1 & 2: Cohort A + B + C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

Source null

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secondary · NOT_POSTED

Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator

Source null

→

secondary · NOT_POSTED

Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EQ-5D · Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT02864992
qol key
qol-0015
source section id
NCT02864992-om-0015
source outcome index
15
instrument
EQ-5D
instrument basis
matched 'eq5d' in the study's own wording
scale title
Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score
measure definition
Source null
time frame
Time from first treatment up to end of study (approximately Month 101)
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Part 1 & 2: Cohort A + B + C: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT02864992
qol key
qol-0016
source section id
NCT02864992-om-0016
source outcome index
16
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Part 1 & 2: Cohort A + B + C: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
measure definition
Source null
time frame
Time from first treatment up to end of study (approximately Month 101)
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Part 1 & 2: Cohort A + B + C: Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT02864992
qol key
qol-0017
source section id
NCT02864992-om-0017
source outcome index
17
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Part 1 & 2: Cohort A + B + C: Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
measure definition
Source null
time frame
Time from first treatment up to end of study (approximately Month 101)
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-emrelis-64185771
nct id
NCT02864992
trial label
Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
applicability
unclear
applicability note
Attached because the study's own record names MET and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
1
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0000
    source section id
    NCT02864992-om-0000
    source outcome index
    0
    endpoint
    Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)
    endpoint definition
    Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
    time origin
    Time from first treatment up to data cutoff (approximately Month 66)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safty Analysis Set included all participants in Cohort A who were administered at least 1 dose of tepotinib, including participants with METex14 skipping alterations not confirmed by a validated central laboratory assay.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0001
    source section id
    NCT02864992-om-0001
    source outcome index
    1
    endpoint
    Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
    endpoint definition
    Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
    time origin
    Time from first treatment up to data cutoff (approximately Month 66)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety Analysis Set included all participants in Cohort B who were administered at least 1 dose of tepotinib, including participants with a MET Amplification.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0002
    source section id
    NCT02864992-om-0002
    source outcome index
    2
    endpoint
    Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
    endpoint definition
    Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
    time origin
    Time from first treatment up to data cutoff (approximately Month 66)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety analysis set included all participants in Cohort C who were administered at least 1 dose of tepotinib.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0003
    source section id
    NCT02864992-om-0003
    source outcome index
    3
    endpoint
    Part 1 & 2: Cohort A + B + C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
    endpoint definition
    Part 1 & 2: Cohort A + B + C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
    time origin
    Time from first treatment up to end of study (approximately Month 101)
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0004
    source section id
    NCT02864992-om-0004
    source outcome index
    4
    endpoint
    Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
    endpoint definition
    Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
    time origin
    Time from first treatment up to end of study (approximately Month 101)
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0005
    source section id
    NCT02864992-om-0005
    source outcome index
    5
    endpoint
    Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
    endpoint definition
    Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
    time origin
    Time from first treatment up to end of study (approximately Month 101)
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Part 1: Cohort A: METex14 Skipping Alterations
    regimen
    Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
    analyzed count
    152
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02864992-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Part 1: Cohort B: MET Amplification
    regimen
    Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02864992-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations
    regimen
    Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
    analyzed count
    161
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02864992-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    harm key
    EG000
    source section id
    NCT02864992-ae
    event group key
    EG000
    event group label
    Part 1 & 2: Cohort A + B + C
    serious affected
    169
    serious at risk
    337
    other affected
    331
    other at risk
    337
    frequency threshold
    5
    collection period
    Time from first treatment up to data cutoff (approximately Month 74)
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    qol key
    qol-0015
    source section id
    NCT02864992-om-0015
    source outcome index
    15
    instrument
    EQ-5D
    instrument basis
    matched 'eq5d' in the study's own wording
    scale title
    Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score
    measure definition
    Source null
    time frame
    Time from first treatment up to end of study (approximately Month 101)
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    qol key
    qol-0016
    source section id
    NCT02864992-om-0016
    source outcome index
    16
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Part 1 & 2: Cohort A + B + C: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    measure definition
    Source null
    time frame
    Time from first treatment up to end of study (approximately Month 101)
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-emrelis-64185771
    nct id
    NCT02864992
    qol key
    qol-0017
    source section id
    NCT02864992-om-0017
    source outcome index
    17
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Part 1 & 2: Cohort A + B + C: Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    measure definition
    Source null
    time frame
    Time from first treatment up to end of study (approximately Month 101)
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice