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A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease


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

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Trial Information

A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease


Inclusion Criteria:



- Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement
must be confirmed by biopsy

- Stable disease or clinical response after primary therapy of chemo-radiation
treatment for unresectable stage III disease

- Primary therapy should be a minimum of 2 cycles of Platinum-based first-line
chemotherapy, given concurrent with thoracic radiation. The combined modality should
consist of either:

- induction (2 cycles) chemotherapy followed by concurrent chemo/RT; or

- concurrent chemo/RT followed by 2 cycles of consolidation chemotherapy; or

- concurrent chemo/RT alone

- A minimum radiation dose of ≥6,000cGy should be administered. Patients must have
completed the primary therapy at least 4 weeks and no later than 6 months prior to
study entry

- ECOG performance status of ≤1

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

Exclusion Criteria:

- Undergone lung cancer specific therapy (including surgery) prior to primary chemo/RT

- Received immunotherapy within 4 weeks prior to study entry

- Received systemic immunosuppressive drugs within 4 weeks prior to study entry

- Received investigational systemic drugs within 4 weeks prior to study entry

- Brain metastases

- Pleural effusion, unless cytologically confirmed to be non-malignant

- 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

- Clinically significant active infection

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

Day 0, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 13, 19, 25, 31, 37, 42, Months 12, 18, 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-305 / EMR 63325-006

NCT ID:

NCT00157196

Start Date:

April 2005

Completion Date:

Related Keywords:

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

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