Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
