Status:
COMPLETED
Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 includ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00157196
Start Date
April 1 2005
End Date
April 1 2012
Last Update
August 18 2015
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