Study of Tecemotide (L-BLP25) in Participants With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Biological: Placebo; Other: Saline; Drug: Single low dose cyclophosphamide; Biological: Tecemotide (L-BLP25)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960115

EMR063325_009

Details and patient eligibility

About

This is a phase I/II study in Japan to evaluate the safety of EMD531444 and its effects on survival time in patients with stage III unresectable non-small cell lung cancer.

Full description

Phase I part is designed to evaluate the safety of EMD531444 930 microgram (mcg) dose to be used in phase II. Phase II part is designed to be conducted as randomized, double blind, placebo controlled study to compare overall survival time in all randomized subjects.

Enrollment: 178 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of greater than or equal to (>=) 50 Gray (Gy). Participant must have completed the primary thoracic chemoradiotherapy at least 4 weeks and no later than 12 weeks prior to randomization
• Written informed consent given before any study-related activities are carried out.
• Histologically or cytologically documented unresectable stage III NSCLC. Cancer stage must be confirmed and documented by Computed Tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scan
• Documented stable disease or objective response, according to RECIST, after primary chemoradiotherapy for unresectable stage III disease, within four weeks prior to randomization
• Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of >= 50 Gy
• Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate bone marrow function
• Greater than or equal to 20 years of age

Exclusion criteria

• Lung cancer-specific therapy (including surgery), other than primary chemoradiotherapy. Note: exploratory surgery before study entry is allowed
• Immunotherapy (e.g., interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) received within four weeks prior to randomization
• Malignant pleural/pericardial effusion or pleural dissemination or separate tumor nodules in the same lobe at initial diagnosis and/or at study entry
• Past or current history of neoplasm other than lung carcinoma, except for adequately 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 five years
• Autoimmune disease
• A recognized immunodeficiency disease including cellular immunodeficiencies, hypogamma-globulinemia, or dysgammaglobulinemia; participants who have hereditary or congenital/acquired immunodeficiencies
• Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy, including presence of diffuse radiation pneumonitis spreading out of the involved field
• Known Hepatitis B and/or C
• Clinically significant hepatic dysfunction
• Clinically significant renal dysfunction
• Clinically significant cardiac disease
• Splenectomy
• Infectious process that, in the opinion of the investigator, could compromise the subject's ability to mount an immune response
• Pregnant or breast-feeding women. Participants whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard. Male and female subjects who have a reproductive ability, unless using effective contraception as determined by the investigator throughout the study until at least 6 months after the last study treatment
• Known drug abuse or alcohol abuse
• Legal incapacity or limited legal capacity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 2 patient groups, including a placebo group

Tecemotide (L-BLP25) + Cyclophosphamide

Experimental group

Description:

Active

Treatment:

Drug: Single low dose cyclophosphamide

Biological: Tecemotide (L-BLP25)

Placebo + Saline

Placebo Comparator group

Description:

Control

Treatment:

Other: Saline

Biological: Placebo