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 or cytologically documented unresectable stage III non-small cell lung cancer (NSCLC)
Documented stable disease or objective response, according to Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST v1.0) after primary concomitant chemo-radiotherapy for unresectable stage III disease, within four weeks (28 days) prior to randomization
Receipt of concomitant chemo-radiotherapy. The chemotherapy-part must have been platinum-based, must have been administered with a minimum of two cycles overlap with radiotherapy (one cycle lasts either 3 or 4 weeks depending on the chemotherapy regimen), and a minimum of two platinum-based chemotherapy administrations must have been given during radiotherapy. Purely radio sensitizing doses of chemotherapy are not acceptable. Radiotherapy must have delivered a radiation dose of \>= (greater than or equal to) 50 Gray (Gy). Induction or consolidation chemotherapy is allowed and if given, should be accounted as part of primary thoracic chemoradiotherapy. 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
A platelet count \>= the lower limit of normal for the site or \>= 100 x 10\^9 per liter (/Liter) (whichever is greater); white blood cell (WBC) \>= 2.5 x 10\^9/Liter and haemoglobin \>= 90 gram per liter (g/L)
\>=18 years of age (or minimum age of legal consent consistent with local regulations, if minimum is greater than \[\>\] 18 years of age)
You may not be if
Pre-Therapies\*:
Prior sequential chemo-radiotherapy
Lung-cancer-specific therapy (including surgery) other than primary chemoradiotherapy
Immunotherapy (e.g., interferons, tumor necrosis factor \[TNF\], interleukins, or biological response modifiers \[granulocyte macrophage colony stimulating factor {GMCSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}\], monoclonal antibodies) within four weeks (28 days) prior to randomization
Investigational systemic drugs (including off-label use of approved products) within four weeks (28 days) prior to randomization
Disease Status:
Metastatic disease
Malignant pleural effusion at initial diagnosis and/or at trial 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
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 active Hepatitis B infection and/or Hepatitis C infection
Signs and symptoms suggestive of transmissible spongiform encephalopathy, or of family members who suffer(ed) from such
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 breastfeeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
Known drug abuse or alcohol abuse
Participation in another clinical trial (excluding purely observational studies) within the past 28 days
Requires concurrent treatment with a non-permitted drug
Known hypersensitivity to any of the trial treatment ingredients
Legal incapacity or limited legal capacity
Any other reason that, in the opinion of the investigator precludes the subject from participating in the trial
Clareo Health | Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population
