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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Treatments: Other: Best standard of care (BSC); Drug: Single low dose cyclophosphamide; Biological: Tecemotide (L-BLP25)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00157196

B25-LG-305 / EMR 63325-006

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

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

Experimental group

Treatment:

Drug: Single low dose cyclophosphamide

Biological: Tecemotide (L-BLP25)

Other: Best standard of care (BSC)