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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival Time

Outcome Description:

Time from randomization to death. Patients without event are censored at the date of last contact, or date lost to follow-up

Outcome Time Frame:

Time from randomization to death or last date known to be alive, reported between day of first patient randomised, Dec 2009, until cut-off date expected Jun 2016

Safety Issue:

No

Principal Investigator

Junliang Cai, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono (Beijing), Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA Darmstadt, Germany

Authority:

China: Ministry of Health

Study ID:

EMR63325-012

NCT ID:

NCT01015443

Start Date:

December 2009

Completion Date:

October 2018

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Carcinoma
  • stage III
  • unresectable
  • vaccine; Stimuvax; L-BLP25
  • Cyclophosphamide
  • EMR 63325-012
  • placebo controlled
  • randomized
  • double blind
  • immunotherapy
  • Merck Serono
  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer in the Asian Population
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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