Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease

NCT ID: NCT00157196

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2012-04-30

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care

Group Type: EXPERIMENTAL

Tecemotide (L-BLP25)

Intervention Type: BIOLOGICAL

After receiving single low-dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide \[L-BLP25\]) at 6-week intervals, commencing at Week 13, until disease progression is documented.

Single low dose cyclophosphamide

Intervention Type: DRUG

A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.

Best standard of care (BSC)

Intervention Type: OTHER

The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.

Interventions

Tecemotide (L-BLP25)

After receiving single low-dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide \[L-BLP25\]) at 6-week intervals, commencing at Week 13, until disease progression is documented.

Intervention Type: BIOLOGICAL

Single low dose cyclophosphamide

A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.

Intervention Type: DRUG

Best standard of care (BSC)

The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

References

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.

Reference Type: RESULT

PMID: 21071331 (View on PubMed)

Other Identifiers

B25-LG-305 / EMR 63325-006

Identifier Type: -

Identifier Source: org_study_id