- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00157196
Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
July 23, 2015 updated by: Merck KGaA, Darmstadt, Germany
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Up to data cut-off date (17 September 2007)
|
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.
|
Up to data cut-off date (17 September 2007)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival Time
Time Frame: Up to data cut-off date (17 September 2007)
|
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.
|
Up to data cut-off date (17 September 2007)
|
Progression Free Survival (PFS) Time
Time Frame: Up to data cut-off date (17 September 2007)
|
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.
|
Up to data cut-off date (17 September 2007)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
August 18, 2015
Last Update Submitted That Met QC Criteria
July 23, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
Other Study ID Numbers
- B25-LG-305 / EMR 63325-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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