Clinical trial NCT00409188 (phase 3, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: single low dose cyclophosphamide, placebo
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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