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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cyclophosphamide; Vaccines

Criteria

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