A Multi-national, Double-blind, Placebo-controlled, Randomized, Phase III Clinical Trial of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Asian Subjects With Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) Who Have Demonstrated Either Stable Disease or Objective Response Following Primary Chemo-radiotherapy
Inclusion Criteria:
- Histologically or cytologically documented unresectable stage III NSCLC.
- Documented stable disease or objective response, according to RECIST after primary
chemo-radiotherapy (either sequential or concomitant) for unresectable stage III
disease, within four 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 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 10⁹/L (whichever
is greater); WBC ≥ 2.5 x 10⁹/L and hemoglobin ≥ 90 g/L
- ≥18 years of age (or minimum age of legal consent consistent with local regulations,
if minimum is > 18 years of age)
Exclusion Criteria:
Pre-Therapies*:
- 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 that in the opinion of the investigator could compromise the
safety of the subject in this trial
- 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