Cancer vaccine study for unresectable stage III non-small cell lung cancer
- Conditions
- on-small cell lung cancer (NSCLC) subjects with unresectable stage III diseaseNon-small cell lung cancer (NSCLC) subjects with unresectable stage III diseaseCancer - Lung - Non small cell
- Registration Number
- ACTRN12607000173493
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1322
Histologically or cytologically documented unresectable stage III NSCLC. -Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST), after primary chemo-radiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks (28 days) prior to randomization.-Receipt of concomitant or sequential chemo-radiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of = 50 Gy. Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible.-Geographically accessible for ongoing follow-up, and committed to comply with the designated visits.-An ECOG (The Eastern Cooperative Oncology Group) performance status of 0-1.
Pre-Therapies:-Undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy.-Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization. -Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization. Disease Status:-Metastatic disease.-Malignant pleural effusion at initial diagnosis and at study entry.-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 that in the opinion of the investigator could compromise the safety of the subject in this study. -A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies. -Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed).-Known Hepatitis B and/or C. Physiological Functions:-Clinically significant hepatic dysfunction.-Clinically significant renal dysfunction.-Clinically significant cardiac disease.-Splenectomy.-Infectious process that in the opinion of the investigator could compromise the subject’s ability to mount an immune response. Standard Safety:-Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator. -Known drug abuse/alcohol abuse.-Legal incapacity or limited legal capacity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary variable of this study is the survival duration. Survival will be measured as the number of months between the date of randomization and the date of death.[The final analysis will take place after the targeted number of events is reached. An independent Data Monitoring Committee will be responsible for periodic evaluations to ensure continued subject safety as well as the validity of the study. In addition, two formal interim analyses are planned.<br>Once treatment is finished, the subject is contacted every 12 weeks to collect survival data.]
- Secondary Outcome Measures
Name Time Method