Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
Condition: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: Tecemotide (L-BLP25); Single low dose cyclophosphamide; Best standard of care (BSC)
Intervention description: 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.
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carcinoma, Non-Small-Cell Lung, L-BLP25, Tecemotide

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.
    

Eligibility 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