Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
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.
Checked against the public recordLast updated Nov 20, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- EMD Serono
- Interventions being studied
- Biological: Tecemotide (L-BLP25); Drug: Single low dose cyclophosphamide; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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) Exclusion Criteria: 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Saint Edward Mercy Medical CenterFort Smith, Arkansas
- Pacific Cancer Medical CenterAnaheim, California
- Glendale Adventist Medical CenterGlendale, California
- Norris Cancer HospitalLos Angeles, California
- Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California
- Clinical Trials and Research Associates, Inc.Montebello, California
- Desert Hematology Oncology Medical Group, IncRancho Mirage, California
- Stockton Hematology Oncology Medical Group, Inc.Stockton, California
- University of Colorado Cancer CenterDenver, Colorado
- Pasco Hernando Oncology Associates P.ABrooksville, Florida
- University of Miami, Sylvester Comprehensive Cancer CenterMiami, Florida
- Pasco Hernando Oncology Associates, PANew Port Richey, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 20, 2015. Always confirm current availability with the study team.