None listed
Conditions
Brief summary
This is a study of a cancer vaccine known as Stimuvax for treating non-small cell lung cancer (NSCLC) at stage 3, where this cannot be operated on surgically. Who is it for? You may be suitable for this study if: • You have stage 3 non-small cell lung cancer that cannot be operated on. • You have received primary platinum chemoradiotherapy. • The cancer is stable or responsive. Trial details Participants will be randomly divided into two groups. Four weeks after the last chemoradiation treatment, one group receives one infusion of cyclophosphamide followed by weekly subcutaneous vaccination with Stimuvax for 8 weeks and then injections are given once every six weeks until any progression of the cancer. The other group will receive a non-active compound. The study aims to monitor survival time and time to any progression of symptoms. Currently there is no standard prescribed treatment for these people following chemoradiotherapy. Stimuvax is designed to stimulate the immune system to respond to a protein found in many cancers including NSCLC. This trial will determine if Stimuvax has beneficial effects after participants cease chemoradiation.
Interventions
Investigational arm:
Pre-treatment: one intravenous infusion of cyclophosphamide (infusion of 300 mg/m2, determined by calculation of the subject's body surface area. A maximum dose of 600mg will be given).
Primary treatment: weekly subcutaneous vaccinations with Stimuvax (subcutaneous injection of 1,000 µg) for 8 consecutive weeks.
Maintenance treatment: vaccinations with Stimuvax (subcutaneous injection of 1,000 µg) at 6-week intervals.
Subjects will be discontinued upon documented disease
Investigational arm: Pre-treatment: one intravenous infusion of cyclophosphamide (infusion of 300 mg/m2, determined by calculation of the subject's body surface area. A maximum dose of 600mg will be given). Primary treatment: weekly subcutaneous vaccinations with Stimuvax (subcutaneous injection of 1,000 µg) for 8 consecutive weeks. Maintenance treatment: vaccinations with Stimuvax (subcutaneous injection of 1,000 µg) at 6-week intervals. Subjects will be discontinued upon documented disease progression.
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically or cytologically documented unresectable stage III NSCLC. -Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST), after primary chemo-radiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks (28 days) prior to randomization.-Receipt of concomitant or sequential chemo-radiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of = 50 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 ECOG (The Eastern Cooperative Oncology Group) performance status of 0-1.
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 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 that in the opinion of the investigator could compromise the safety of the subject in this study. -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
Outcome results
None listed