Status:
COMPLETED
Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 I...
Detailed Description
Ancillary Trial: An exploratory investigation of immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination. The ancillary study is a sub-study within START. This is an exp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
1513 Patients enrolled
Trial Details
Trial ID
NCT00409188
Start Date
January 1 2007
End Date
April 1 2015
Last Update
November 20 2015
Active Locations (290)
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1
Saint Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72901
2
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
3
Glendale Adventist Medical Center
Glendale, California, United States, 91206
4
Norris Cancer Hospital
Los Angeles, California, United States, 90033