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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cyclophosphamide

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