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← Stage IV recurrent Non-Small Cell Lung Cancer

NCT02408016 · STUDY IN CONTEXT

Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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.

exploratory · NOT_POSTED

Frequency of transferred T cells at biopsied tumor sites between the Tn and Tcm groups will be assessed.

Source null

→

exploratory · NOT_POSTED

Tetramer+ cells from peripheral blood, if detectable and available in sufficient number, evaluated for production of intracellular cytokines including interferon-gamma (IFN-gamma), tumor necrosis factor alpha (TNF-alpha), and IL-2. Intranuclear Ki-67 expression assessed on recovered tetramer+ T cells. Based on available numbers, ex vivo proliferative capacity after infusion assessed by labeling cells with carboxyfluorescein succinimidyl ester dye and measuring dilution in response to peptide stimulation. Phenotype of tetramer+ antigen-specific cells assessed using established immunophenotyping

Source null

→

exploratory · NOT_POSTED

The potential efficacy of the infused cells will be assessed and the substrate cell (TN or TCM) that is most effective based on the TTP of patients who have persisting TN cells to that of patients who have persisting TCM cells 3 months after the last infusion will be determined.

Source null

→

primary · POSTED

Based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

No patients were treated in Arm II.

→

primary · POSTED

There were products generated for 11 participants and 10 participants were treated on the study. 8 participants received an infusion with Tn and Tcm cells. 1 participant received infusions with only Tn cells. 1 participant received their last infusion with only Tcm cells. The one participant that was not treated did successfully have Tn and Tcm cells generated but they were not treated due to their condition worsening.

No patients were treated in Arm II.

→

primary · POSTED

In vivo persistence of cells generated from the TN subset with cells generated from the TCM subset will be directly compared within each patient by high throughput T-cell receptor (TCR) beta sequencing. The one-sample T test will be used to assess the difference in mean persistence between groups, in which the outcome for each patient is the time to disappearance of infused cytotoxic T lymphocytes.

No patients were treated in Arm II

→

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

FACT · Functional Capacity of Transferred Cells, Measured by Production of Intracellular Cytokines

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-stage-iv-recurrent-064adc80
nct id
NCT02408016
qol key
qol-0004
source section id
NCT02408016-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Functional Capacity of Transferred Cells, Measured by Production of Intracellular Cytokines
measure definition
Tetramer+ cells from peripheral blood, if detectable and available in sufficient number, evaluated for production of intracellular cytokines including interferon-gamma (IFN-gamma), tumor necrosis factor alpha (TNF-alpha), and IL-2. Intranuclear Ki-67 expression assessed on recovered tetramer+ T cells. Based on available numbers, ex vivo proliferative capacity after infusion assessed by labeling cells with carboxyfluorescein succinimidyl ester dye and measuring dilution in response to peptide stimulation. Phenotype of tetramer+ antigen-specific cells assessed using established immunophenotyping
time frame
Up to 15 years
analysis role
exploratory
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-stage-iv-recurrent-064adc80
nct id
NCT02408016
trial label
Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma
applicability
unclear
applicability note
Attached because the study's own record describes recurrent 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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0003
    source section id
    NCT02408016-om-0003
    source outcome index
    3
    endpoint
    Frequency of Transferred T Cells at Biopsied Tumor Sites Between the T Cell (Tn) and Memory T Cell (Tcm) Groups
    endpoint definition
    Frequency of transferred T cells at biopsied tumor sites between the Tn and Tcm groups will be assessed.
    time origin
    Up to 15 years
    analysis role
    exploratory
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0004
    source section id
    NCT02408016-om-0004
    source outcome index
    4
    endpoint
    Functional Capacity of Transferred Cells, Measured by Production of Intracellular Cytokines
    endpoint definition
    Tetramer+ cells from peripheral blood, if detectable and available in sufficient number, evaluated for production of intracellular cytokines including interferon-gamma (IFN-gamma), tumor necrosis factor alpha (TNF-alpha), and IL-2. Intranuclear Ki-67 expression assessed on recovered tetramer+ T cells. Based on available numbers, ex vivo proliferative capacity after infusion assessed by labeling cells with carboxyfluorescein succinimidyl ester dye and measuring dilution in response to peptide stimulation. Phenotype of tetramer+ antigen-specific cells assessed using established immunophenotyping
    time origin
    Up to 15 years
    analysis role
    exploratory
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0005
    source section id
    NCT02408016-om-0005
    source outcome index
    5
    endpoint
    Time to Progression (TTP) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and RECIST 1.1 Mesothelioma Modified
    endpoint definition
    The potential efficacy of the infused cells will be assessed and the substrate cell (TN or TCM) that is most effective based on the TTP of patients who have persisting TN cells to that of patients who have persisting TCM cells 3 months after the last infusion will be determined.
    time origin
    3 months after last infusion
    analysis role
    exploratory
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0000
    source section id
    NCT02408016-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Adverse Events
    endpoint definition
    Based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
    time origin
    Up to 6 months after the first T cell infusion
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were treated in Arm II.
    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-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0001
    source section id
    NCT02408016-om-0001
    source outcome index
    1
    endpoint
    Count of Patients for Which T Cells Are Successfully Generated and Infused and Whether Only TN or TCM Could be Generated
    endpoint definition
    There were products generated for 11 participants and 10 participants were treated on the study. 8 participants received an infusion with Tn and Tcm cells. 1 participant received infusions with only Tn cells. 1 participant received their last infusion with only Tcm cells. The one participant that was not treated did successfully have Tn and Tcm cells generated but they were not treated due to their condition worsening.
    time origin
    Up to 4 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were treated in Arm II.
    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-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0002
    source section id
    NCT02408016-om-0002
    source outcome index
    2
    endpoint
    Persistence of Transduced T Cells
    endpoint definition
    In vivo persistence of cells generated from the TN subset with cells generated from the TCM subset will be directly compared within each patient by high throughput T-cell receptor (TCR) beta sequencing. The one-sample T test will be used to assess the difference in mean persistence between groups, in which the outcome for each patient is the time to disappearance of infused cytotoxic T lymphocytes.
    time origin
    Up to 100 days after the last T cell infusion
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were treated in Arm II
    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-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)
    regimen
    Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)
    regimen
    Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm II (T Lymphocytes, IL-2, Surgery)
    regimen
    Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)
    regimen
    Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)
    regimen
    Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Arm II (T Lymphocytes, IL-2, Surgery)
    regimen
    Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)
    regimen
    Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on days 0 and 14, cyclophosphamide IV on days 11 and 12, and aldesleukin SC BID for 14 days. Patients who have received radiation to the chest/lung tissue may receive gene-transduced T lymphocytes 90 days after completion of radiation. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)
    regimen
    Patients receive cyclophosphamide IV on days -3 and -2, autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV on day 0, and aldesleukin SC BID for 14 days. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Arm II (T Lymphocytes, IL-2, Surgery)
    regimen
    Patients receive autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes IV between 24-96 hours after the last dose of chemotherapy and receive aldesleukin SC BID for 14 days. Patients then undergo surgery within 3-4 weeks after the T-cell infusion. Aldesleukin: Given SC Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgical resection
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02408016-om-0002#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    harm key
    EG000
    source section id
    NCT02408016-ae
    event group key
    EG000
    event group label
    Arm I, Stage I (T Lymphocytes, Cyclophosphamide, IL-2)
    serious affected
    0
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    0
    collection period
    12 months
    event definition
    No patients were treated in Arm II.
    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-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    harm key
    EG001
    source section id
    NCT02408016-ae
    event group key
    EG001
    event group label
    Arm I, Stage II (T Lymphocytes, Cyclophosphamide, IL-2)
    serious affected
    0
    serious at risk
    4
    other affected
    3
    other at risk
    4
    frequency threshold
    0
    collection period
    12 months
    event definition
    No patients were treated in Arm II.
    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-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    harm key
    EG002
    source section id
    NCT02408016-ae
    event group key
    EG002
    event group label
    Arm II (T Lymphocytes, IL-2, Surgery)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    12 months
    event definition
    No patients were treated in Arm II.
    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-stage-iv-recurrent-064adc80
    nct id
    NCT02408016
    qol key
    qol-0004
    source section id
    NCT02408016-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Functional Capacity of Transferred Cells, Measured by Production of Intracellular Cytokines
    measure definition
    Tetramer+ cells from peripheral blood, if detectable and available in sufficient number, evaluated for production of intracellular cytokines including interferon-gamma (IFN-gamma), tumor necrosis factor alpha (TNF-alpha), and IL-2. Intranuclear Ki-67 expression assessed on recovered tetramer+ T cells. Based on available numbers, ex vivo proliferative capacity after infusion assessed by labeling cells with carboxyfluorescein succinimidyl ester dye and measuring dilution in response to peptide stimulation. Phenotype of tetramer+ antigen-specific cells assessed using established immunophenotyping
    time frame
    Up to 15 years
    analysis role
    exploratory
    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