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Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tecemotide (L-BLP25)
Single low dose cyclophosphamide
Best standard of care (BSC)
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Non-Small-Cell Lung, L-BLP25, Tecemotide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement must be confirmed by biopsy Stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage III disease Primary therapy should be a minimum of 2 cycles of Platinum-based first-line chemotherapy, given concurrent with thoracic radiation. The combined modality should consist of either: induction (2 cycles) chemotherapy followed by concurrent chemo-radiation therapy; or concurrent chemo-radiation therapy followed by 2 cycles of consolidation chemotherapy; or concurrent chemoradiation therapy alone A minimum radiation dose of greater than or equal to (>=) 6,000 centigray (cGy) should be administered. Subjects must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1 Ability to understand and willingness to sign a written informed consent Other protocol defined inclusion criteria could apply Exclusion Criteria: Undergone lung cancer specific therapy (including surgery) prior to primary chemo-radiation therapy Received immunotherapy/systemic immunosuppressive drugs/investigational systemic drugs within 4 weeks prior to study entry Subjects with brain metastases, pleural effusion, unless cytologically confirmed to be non-malignant Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years Autoimmune disease or immunodeficiency Clinically significant hepatic, renal dysfunction or cardiac diseases Clinically significant active infection Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator Other protocol defined inclusion criteria could apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
    TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.

    Secondary Outcome Measures

    Survival Time
    Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis.
    Progression Free Survival (PFS) Time
    PFS was defined as duration from first administration of trial treatment until progressive disease [PD] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment.

    Full Information

    First Posted
    September 8, 2005
    Last Updated
    July 23, 2015
    Sponsor
    Merck KGaA, Darmstadt, Germany
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00157196
    Brief Title
    Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
    Official Title
    A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2005 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck KGaA, Darmstadt, Germany

    4. Oversight

    5. Study Description

    Brief Summary
    The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This population includes Stage IIIA NSCLC subjects, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of subjects treated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
    Keywords
    Carcinoma, Non-Small-Cell Lung, L-BLP25, Tecemotide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Tecemotide (L-BLP25)
    Intervention Description
    After receiving single low-dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide [L-BLP25]) at 6-week intervals, commencing at Week 13, until disease progression is documented.
    Intervention Type
    Drug
    Intervention Name(s)
    Single low dose cyclophosphamide
    Intervention Description
    A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Best standard of care (BSC)
    Intervention Description
    The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
    Description
    TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.
    Time Frame
    Up to data cut-off date (17 September 2007)
    Secondary Outcome Measure Information:
    Title
    Survival Time
    Description
    Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis.
    Time Frame
    Up to data cut-off date (17 September 2007)
    Title
    Progression Free Survival (PFS) Time
    Description
    PFS was defined as duration from first administration of trial treatment until progressive disease [PD] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment.
    Time Frame
    Up to data cut-off date (17 September 2007)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement must be confirmed by biopsy Stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage III disease Primary therapy should be a minimum of 2 cycles of Platinum-based first-line chemotherapy, given concurrent with thoracic radiation. The combined modality should consist of either: induction (2 cycles) chemotherapy followed by concurrent chemo-radiation therapy; or concurrent chemo-radiation therapy followed by 2 cycles of consolidation chemotherapy; or concurrent chemoradiation therapy alone A minimum radiation dose of greater than or equal to (>=) 6,000 centigray (cGy) should be administered. Subjects must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1 Ability to understand and willingness to sign a written informed consent Other protocol defined inclusion criteria could apply Exclusion Criteria: Undergone lung cancer specific therapy (including surgery) prior to primary chemo-radiation therapy Received immunotherapy/systemic immunosuppressive drugs/investigational systemic drugs within 4 weeks prior to study entry Subjects with brain metastases, pleural effusion, unless cytologically confirmed to be non-malignant Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years Autoimmune disease or immunodeficiency Clinically significant hepatic, renal dysfunction or cardiac diseases Clinically significant active infection Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator Other protocol defined inclusion criteria could apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Responsible
    Organizational Affiliation
    Merck KGaA, Darmstadt, Germany
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21071331
    Citation
    Butts C, Murray RN, Smith CJ, Ellis PM, Jasas K, Maksymiuk A, Goss G, Ely G, Beier F, Soulieres D. A multicenter open-label study to assess the safety of a new formulation of BLP25 liposome vaccine in patients with unresectable stage III non-small-cell lung cancer. Clin Lung Cancer. 2010 Nov 1;11(6):391-5. doi: 10.3816/CLC.2010.n.101.
    Results Reference
    result

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    Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease

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