Clinical trial NCT00157196: Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Keywords: Carcinoma, Non-Small-Cell Lung, L-BLP25, Tecemotide
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This population includes Stage IIIA NSCLC subjects, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of subjects treated.


Eligibility criteria: 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-radiation therapy; or
  * concurrent chemo-radiation therapy followed by 2 cycles of consolidation chemotherapy; or
  * concurrent chemoradiation therapy alone
* A minimum radiation dose of greater than or equal to (\>=) 6,000 centigray (cGy) should be administered. Subjects must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (\<=) 1
* Ability to understand and willingness to sign a written informed consent
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Undergone lung cancer specific therapy (including surgery) prior to primary chemo-radiation therapy
* Received immunotherapy/systemic immunosuppressive drugs/investigational systemic drugs within 4 weeks prior to study entry
* Subjects with 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 dysfunction or cardiac diseases
* Clinically significant active infection
* Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
* Other protocol defined inclusion criteria could apply

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)
timeFrame: Up to data cut-off date (17 September 2007)
Secondary outcomes:
measure: Survival Time
timeFrame: Up to data cut-off date (17 September 2007)
measure: Progression Free Survival (PFS) Time
timeFrame: Up to data cut-off date (17 September 2007)
Other outcomes:
Locations:
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Butts C, Murray RN, Smith CJ, Ellis PM, Jasas K, Maksymiuk A, Goss G, Ely G, Beier F, Soulieres D. A multicenter open-label study to assess the safety of a new formulation of BLP25 liposome vaccine in patients with unresectable stage III non-small-cell lung cancer. Clin Lung Cancer. 2010 Nov 1;11(6):391-5. doi: 10.3816/CLC.2010.n.101.