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A Multicenter Phase IIb Randomized, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

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Trial Information

A Multicenter Phase IIb Randomized, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer


Inclusion Criteria:



- Stage IIIB or stage IV NSCLC

- Stable disease or a clinical response following first-line treatment, consisting of
either chemotherapy alone or chemotherapy and radiotherapy. Patients must have
completed the first-line treatment at least 3 weeks prior to study entry

- ECOG performance status of ≤2

- Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

- Received immunotherapy within 4 weeks prior to study entry

- Received immunosuppressive drugs within 3 weeks prior to study entry

- Patients with known brain metastases

- 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 or immunodeficiency

- Clinically significant hepatic, renal or cardiac dysfunction

- Patients with clinically significant active infection

- Pregnant or breast feeding women, women of childbearing potential, unless using
effective contraception as determined by the investigator

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Document safety profile of 930 μg of L-BLP25.

Outcome Time Frame:

Day 0, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 13, 19, 25, 31, 37, 43, 49, 55, Month 24. Additional inquires on survival until death.

Safety Issue:

No

Principal Investigator

Martin Falk, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck KGaA

Authority:

Canada: Health Canada

Study ID:

B25-LG-304 / EMR 63325-005

NCT ID:

NCT00157209

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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