The purpose of this study is to determine whether the cancer vaccine Stimuvax in addition to best supportive care is effective in prolonging the lives of patients with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.

Official Title

A Multi-Center Phase III Randomized, Double-Blind Placebo-Controlled Study of the Cancer Vaccine Stimuvax (L-BLP25 or BLP25 Liposome Vaccine) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.

Conditions

  • Non-Small Cell Lung Cancer

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

  • Primary Outcomes: To compare survival duration of all randomized subjects by treatment arm
  • Secondary Outcomes: to compare all randomized subjects by treatment arm for: Time To Symptom Progression (TTSP) as measured by the Lung Cancer Symptom Scale (LCSS); Time To Progression (TTP) as determined by the investigator; one-, two- and three-year survival; Safety

Study Start

December 2006; Expected completion: December 2010

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Male and female; >=18 years are eligible for randomization.
  • Histologically or cytologically documented unresectable stage III NSCLC.
  • Documented stable disease or objective response, according to RECIST, after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks(28 days) prior to randomization.
  • Receipt of concomitant or sequential chemoradiotherapy, 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 performance status of 0-1.

Exclusion Criteria:

  • 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 nonmelanoma 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

Total Enrolment

1322 (expected)

Contact Details

Research Site, Nedlands, Western Australia, Australia; Recruiting