Status:
COMPLETED
Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective open label, controlled, randomized study to test the safety and efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of subjects with Stage IIIB ...
Eligibility Criteria
Inclusion
- Stage IIIB or Stage IV NSCLC
- Stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. Subjects must have completed the first-line treatment at least 3 weeks prior to study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (\>=) 2
- Ability to understand and willingness to sign a written informed consent
- Other protocol-defined inclusion criteria could apply
Exclusion
- Received immunotherapy within 4 weeks prior to study entry
- Received immunosuppressive drugs within 3 weeks prior to study entry
- Subjects with known brain metastases
- 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 or cardiac dysfunction
- Subjects with clinically significant active infection
- Pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
- Other protocol-defined exclusion criteria could apply
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00157209
Start Date
August 1 2000
End Date
July 1 2012
Last Update
November 18 2015
Active Locations (1)
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1
Please Contact the Merck KGaA Communication Center
Darmstadt, Germany