Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone. A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.

Key facts

Study ID

NCT00409188

Run by

EMD Serono

People needed

1513

Starts

2007-01-01

Expected to finish

2015-04-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented unresectable stage III non-small cell lung cancer (NSCLC)
• Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST), after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks (28 days) 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 Gray (Gy). Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible
• Geographically accessible for ongoing follow-up, and committed to comply with the designated visits
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• A platelet count > 140 x 10\^9/Liter; white blood cells (WBC) > 2.5 x 10\^9/Liter and hemoglobin > 90 gram per liter (g/L)

You may not qualify if…

• Pre-Therapies:
• Undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy
• Receipt of 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) within 4 weeks (28 days) prior to randomization
• Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization
• Disease Status:
• Metastatic disease
• Malignant pleural effusion at initial diagnosis and/or at study entry
• 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
• A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
• Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
• Known Hepatitis B and/or C
• Physiological Functions:
• 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
• Standard Safety:
• Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
• Known drug abuse/alcohol abuse
• Legal incapacity or limited legal capacity

Where it is running

• Pacific Cancer Medical Center — Anaheim, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Norris Cancer Hospital — Los Angeles, California, United States
• Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• Clinical Trials and Research Associates, Inc. — Montebello, California, United States
• Desert Hematology Oncology Medical Group, Inc — Rancho Mirage, California, United States
• Stockton Hematology Oncology Medical Group, Inc. — Stockton, California, United States
• University of Colorado Cancer Center — Denver, Colorado, United States
• Pasco Hernando Oncology Associates P.A — Brooksville, Florida, United States
• University of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Pasco Hernando Oncology Associates, PA — New Port Richey, Florida, United States
• Florida Hospital Memorial System — Ormond Beach, Florida, United States
• Southern Illinois Hematology/Oncology — Centralia, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Kentucky Cancer Center — Hazard, Kentucky, United States
• Leonard J. Chabert Medical Center — Houma, Louisiana, United States
• Hematology and Oncology Specialists, LLC — Metarie, Louisiana, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• University of Maryland, Marlene and Steward Greenbaum Cancer Center — Baltimore, Maryland, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Oncology Care Associates — Saint Joseph, Michigan, United States
• University of Minnesota Physicians, Masonic Cancer Center — Minneapolis, Minnesota, United States
• Saint Louis University Cance Center — St Louis, Missouri, United States
• Saint Edward Mercy Medical Center — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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