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← OPDIVO: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy

NCT01625234 · STUDY IN CONTEXT

Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer

Draft scope assessment: unclear. Attached because the study's own record names ALK. 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

To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent.

Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1. For Phase study, patients must have NSCLC with ALK genomic alterations.

→

secondary · POSTED

To explore the preliminary clinical tumor response after treatment with X-396 (ensartinib) given as a single agent in ALK positive patients at 225 mg QD. Subjects were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria (and CNS lesions were also assessed by modified Response Assessment in Neuro-Oncology). Assessments by CT or MRI were performed after every even cycle of treatment. All assessments were to be performed within 7 days of the scheduled day of assessment. Tumor lesions followed on physical examination must have been assessed on Day 1 of each cycle and at the End-of-Study Treatment Visit.

The Tumor response evaluation population (Recommended Phase 2 Dose only) consisted of subjects who were ALK+ at 225 mg QD, completed at least 1 cycle of treatment, and had a post-baseline response assessment.

→

secondary · POSTED

To characterize the preliminary pharmacokinetics including Cmax f X-396 given as a single agent

Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.For Phase II of the study, patients must have NSCLC with ALK genomic alterations.

→

secondary · POSTED

To characterize the preliminary pharmacokinetics including T max of X-396 given as a single agent

Source null

→

secondary · POSTED

To characterize the preliminary pharmacokinetics including AUC of X-396 given as a single agent

Source null

→

secondary · POSTED

To characterize the preliminary pharmacokinetics including half life of X-396 given as a single agent

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-opdivo-9408611e
nct id
NCT01625234
trial label
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
applicability
unclear
applicability note
Attached because the study's own record names ALK. 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
7
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0000
    source section id
    NCT01625234-om-0000
    source outcome index
    0
    endpoint
    Maximum Tolerated Dose
    endpoint definition
    To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent.
    time origin
    28 Days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1. For Phase study, patients must have NSCLC with ALK genomic alterations.
    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-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0001
    source section id
    NCT01625234-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Preliminary Tumor Response in ALK Positive Patients at 225 mg QD
    endpoint definition
    To explore the preliminary clinical tumor response after treatment with X-396 (ensartinib) given as a single agent in ALK positive patients at 225 mg QD. Subjects were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria (and CNS lesions were also assessed by modified Response Assessment in Neuro-Oncology). Assessments by CT or MRI were performed after every even cycle of treatment. All assessments were to be performed within 7 days of the scheduled day of assessment. Tumor lesions followed on physical examination must have been assessed on Day 1 of each cycle and at the End-of-Study Treatment Visit.
    time origin
    18 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Tumor response evaluation population (Recommended Phase 2 Dose only) consisted of subjects who were ALK+ at 225 mg QD, completed at least 1 cycle of treatment, and had a post-baseline response assessment.
    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-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    source section id
    NCT01625234-om-0002
    source outcome index
    2
    endpoint
    Plasma Concentrations Cmax for Day 1
    endpoint definition
    To characterize the preliminary pharmacokinetics including Cmax f X-396 given as a single agent
    time origin
    24 hours
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.For Phase II of the study, patients must have NSCLC with ALK genomic alterations.
    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-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0003
    source section id
    NCT01625234-om-0003
    source outcome index
    3
    endpoint
    Plasma Tmax on Day 1
    endpoint definition
    To characterize the preliminary pharmacokinetics including T max of X-396 given as a single agent
    time origin
    24 hours
    analysis role
    secondary
    reporting status
    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-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0004
    source section id
    NCT01625234-om-0004
    source outcome index
    4
    endpoint
    Plasma Concentrations AUC on Day 1
    endpoint definition
    To characterize the preliminary pharmacokinetics including AUC of X-396 given as a single agent
    time origin
    0, 0.5h, 1.0h , 2.0 h, 4.0h, 6.0h, 8.0h, 24.0h,
    analysis role
    secondary
    reporting status
    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-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0005
    source section id
    NCT01625234-om-0005
    source outcome index
    5
    endpoint
    Plasma Concentrations Half-life on Day 1
    endpoint definition
    To characterize the preliminary pharmacokinetics including half life of X-396 given as a single agent
    time origin
    24 hours
    analysis role
    secondary
    reporting status
    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-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Phase I/II X:396 Ensartinib
    regimen
    All patients treated in the escalating doses from 25 mg -250 mg
    analyzed count
    131
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0001
    arm key
    OG000
    arm label
    X-396 (Ensartinib) 225 mg
    regimen
    RP2D 225 mg For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort
    analyzed count
    81
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Phase I: X-396 (Ensartinib) at 25mg
    regimen
    Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
    regimen
    RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Phase I: X-396 (Ensartinib) at 50 mg
    regimen
    Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG002
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Phase I: X-396 (Ensartinib) at 100 mg
    regimen
    Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG003
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG004
    arm label
    Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
    regimen
    Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG004
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG005
    arm label
    Phase I: X-396 (Ensartinib) at 250mg
    regimen
    Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG005
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG006
    arm label
    Phase I: X-396 (Ensartinib) at 225mg
    regimen
    Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG006
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG007
    arm label
    Phase II: X-396 (Ensartinib) at 225 mg (Fed)
    regimen
    RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG007
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0002
    arm key
    OG008
    arm label
    Phase I: X-396 (Ensartinib) at 200 mg (Fed)
    regimen
    Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0002#groups/OG008
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Phase I: X-396 (Ensartinib) at 25mg
    regimen
    Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01625234-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    harm key
    EG000
    source section id
    NCT01625234-ae
    event group key
    EG000
    event group label
    Phase I: X-396 (Ensartinib) at 25 mg
    serious affected
    1
    serious at risk
    4
    other affected
    3
    other at risk
    4
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
    event definition
    AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
    undenominated 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-opdivo-9408611e
    nct id
    NCT01625234
    harm key
    EG001
    source section id
    NCT01625234-ae
    event group key
    EG001
    event group label
    Phase I: X-396 (Ensartinib) at 50 mg
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
    event definition
    AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
    undenominated 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-opdivo-9408611e
    nct id
    NCT01625234
    harm key
    EG002
    source section id
    NCT01625234-ae
    event group key
    EG002
    event group label
    Phase I: X-396 (Ensartinib) at 100 mg
    serious affected
    2
    serious at risk
    5
    other affected
    4
    other at risk
    5
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
    event definition
    AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
    undenominated note
    Source null
    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-opdivo-9408611e
    nct id
    NCT01625234
    harm key
    EG003
    source section id
    NCT01625234-ae
    event group key
    EG003
    event group label
    Phase I: X-396 (Ensartinib) at 200 mg
    serious affected
    6
    serious at risk
    11
    other affected
    9
    other at risk
    11
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
    event definition
    AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
    undenominated 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-opdivo-9408611e
    nct id
    NCT01625234
    harm key
    EG004
    source section id
    NCT01625234-ae
    event group key
    EG004
    event group label
    Phase I: X-396 (Ensartinib) at 225 mg
    serious affected
    2
    serious at risk
    4
    other affected
    2
    other at risk
    4
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
    event definition
    AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
    undenominated 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-opdivo-9408611e
    nct id
    NCT01625234
    harm key
    EG005
    source section id
    NCT01625234-ae
    event group key
    EG005
    event group label
    Phase I: X-396 (Ensartinib) at 250 mg
    serious affected
    5
    serious at risk
    10
    other affected
    9
    other at risk
    10
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
    event definition
    AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01625234
    harm key
    EG006
    source section id
    NCT01625234-ae
    event group key
    EG006
    event group label
    Phase II: X-396 (Ensartinib) at 225 mg
    serious affected
    41
    serious at risk
    94
    other affected
    84
    other at risk
    94
    frequency threshold
    5
    collection period
    From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
    event definition
    AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
    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
    setting source links

      Preserved source evidence · Not medical advice