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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 20, 2015 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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)
- 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.