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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.
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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:
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
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Interventional model
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22 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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