Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Tecemotide; Single low dose cyclophosphamide; Placebo; Saline; Best Supportive Care (BSC)
Intervention description: Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 918 microgram (mcg) of tecemotide (L-BLP25) at Week 1, 2, 3, 4, 5, 6, 7, and 8 (primary treatment phase) and then at 6-Week intervals, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinues for any other reason.; A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first administration of tecemotide.; Subjects will receive 8 consecutive weekly subcutaneous vaccinations of tecemotide (L-BLP25) matching placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinues for any other reason.; A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination.; The BSC will be provided as per the investigator's discretion, and is not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 285.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Carcinoma; Tecemotide; L-BLP25; Cyclophosphamide; placebo controlled; Non-Small Cell Lung Cancer

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 Asian subjects with
      unresectable stage III non-small cell lung cancer in comparison to a placebo plus best
      supportive care (a so-called placebo controlled study).
    

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 Version 1.0 (RECIST v1.0) after primary concomitant
             chemo-radiotherapy for unresectable stage III disease, within four weeks (28 days)
             prior to randomization

          -  Receipt of concomitant chemo-radiotherapy. The chemotherapy-part must have been
             platinum-based, must have been administered with a minimum of two cycles overlap with
             radiotherapy (one cycle lasts either 3 or 4 weeks depending on the chemotherapy
             regimen), and a minimum of two platinum-based chemotherapy administrations must have
             been given during radiotherapy. Purely radio sensitizing doses of chemotherapy are not
             acceptable. Radiotherapy must have delivered a radiation dose of >= (greater than or
             equal to) 50 Gray (Gy). Induction or consolidation chemotherapy is allowed and if
             given, should be accounted as part of primary thoracic chemoradiotherapy. 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 or 1

          -  A platelet count >= the lower limit of normal for the site or >= 100 x 10^9 per liter
             (/Liter) (whichever is greater); white blood cell (WBC) >= 2.5 x 10^9/Liter and
             haemoglobin >= 90 gram per liter (g/L)

          -  >=18 years of age (or minimum age of legal consent consistent with local regulations,
             if minimum is greater than [>] 18 years of age)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

        Pre-Therapies*:

          -  Prior sequential chemo-radiotherapy

          -  Lung-cancer-specific therapy (including surgery) other than primary chemoradiotherapy

          -  Immunotherapy (e.g., interferons, tumor necrosis factor [TNF], interleukins, or
             biological response modifiers [granulocyte macrophage colony stimulating factor
             {GMCSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating
             factor {M-CSF}], monoclonal antibodies) within four weeks (28 days) prior to
             randomization

          -  Investigational systemic drugs (including off-label use of approved products) within
             four weeks (28 days) prior to randomization

        Disease Status:

          -  Metastatic disease

          -  Malignant pleural effusion at initial diagnosis and/or at trial 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 active Hepatitis B infection and/or Hepatitis C infection

          -  Signs and symptoms suggestive of transmissible spongiform encephalopathy, or of family
             members who suffer(ed) from such

        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 breastfeeding women, women of childbearing potential, unless using
             effective contraception as determined by the investigator

          -  Known drug abuse or alcohol abuse

          -  Participation in another clinical trial (excluding purely observational studies)
             within the past 28 days

          -  Requires concurrent treatment with a non-permitted drug

          -  Known hypersensitivity to any of the trial treatment ingredients

          -  Legal incapacity or limited legal capacity

          -  Any other reason that, in the opinion of the investigator precludes the subject from
             participating in the trial