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Combined Phase I/II Clinical Study of EMD531444(L-BLP25 or BLP25 Liposome Vaccine) in Subjects With Stage III Unresectable Non-small Cell Lung Cancer Following Primary Chemoradiotherapy


Phase 1/Phase 2
20 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Combined Phase I/II Clinical Study of EMD531444(L-BLP25 or BLP25 Liposome Vaccine) in Subjects With Stage III Unresectable Non-small Cell Lung Cancer Following Primary Chemoradiotherapy


Phase I part is designed to evaluate the safety of EMD531444 930mcg dose to be used in phase
II. Phase II part is designed to be conducted as randomized, double blind, placebo
controlled study to compare overall survival time in all randomized subjects.


Inclusion Criteria:



- 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.
Subject must have completed the primary thoracic chemoradiotherapy at least 4 weeks
and no later than 12 weeks prior to randomization.

- Written informed consent given before any study-related activities are carried out.

- Histologically or cytologically documented unresectable stage III NSCLC. Cancer stage
must be confirmed and documented by CT-, MRI-, or PET scan.

- Documented stable disease or objective response, according to RECIST, after primary
chemoradiotherapy for unresectable stage III disease, within four weeks 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.

- ECOG performance status of 0 or 1.

- Adequate bone marrow function.

- ≥ 20 years of age.

Exclusion Criteria:

- Lung cancer-specific therapy (including surgery), other than primary
chemoradiotherapy. Note: exploratory surgery before study entry is allowed.

- 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) received within four weeks prior
to randomization.

- Malignant pleural/pericardial effusion or pleural dissemination or separate tumor
nodules in the same lobe at initial diagnosis and/or at study entry.

- Past or current history of neoplasm other than lung carcinoma, except for adequately
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 five years.

- Autoimmune disease.

- A recognized immunodeficiency disease including cellular immunodeficiencies,
hypogamma-globulinemia, or dysgammaglobulinemia; subjects who have hereditary or
congenital/acquired immunodeficiencies.

- Any preexisting medical condition requiring chronic steroid or immunosuppressive
therapy, including presence of diffuse radiation pneumonitis spreading out of the
involved field.

- Known Hepatitis B and/or C.

- 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.

- Pregnant or breast-feeding women. Subjects whom the investigator considers may be at
risk of pregnancy will have a pregnancy test performed per institutional standard.
Male and female subjects who have a reproductive ability, unless using effective
contraception as determined by the investigator throughout the study until at least 6
months after the last study treatment.

- Known drug abuse or alcohol abuse.

- 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 Time Frame:

The date of randomization; week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14; every 6 weeks after week 14; 6 weeks after last vaccination; 12 weeks after last vaccination. Additional inquires on survival until death.

Safety Issue:

No

Principal Investigator

Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono Co. Ltd. an affiliate of Merck KGaA, Darmstadt, Germany

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

EMR063325_009

NCT ID:

NCT00960115

Start Date:

December 2008

Completion Date:

June 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Stage III
  • EMD531444
  • L-BLP25
  • Cyclophosphamide
  • Immunotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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