Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Tecemotide; Placebo; Cyclophosphamide (CPA); Saline (sodium chloride)
Intervention description: Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.; Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.; CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide.; Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent [%] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.
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: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carcinoma, Non-Small-Cell Lung; Tecemotide; Placebo; NSCLC; L-BLP25

Summary:

      This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in
      subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated
      either stable disease or objective response following primary concurrent chemo-radiotherapy
      (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus
      subjects treated with tecemotide-matching placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent, before any trial-related activities are carried out

          -  Histologically or cytologically documented unresectable stage III NSCLC, including
             bronchioalveolar carcinomas. Cancer stage must be confirmed and documented by computed
             tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography
             (PET) scan

          -  Prior concurrent CRT which is defined as follows:

               -  Minimum of 2 cycles of platinum-based chemotherapy

               -  Radiotherapy with a total tumor dose greater than equal to (>=) 60 Gray and a
                  single fraction dose >= 1.8 Gray

               -  Overlap of radiotherapy with minimum 2 cycles of platinum-based chemotherapy (one
                  cycle is defined as either 3 or 4 weeks depending on the chemotherapy regimen). A
                  deviation of 2 to 3 days from an exact overlap is acceptable. Purely
                  radiosensitizing doses of chemotherapy are not acceptable (for example [e.g.],
                  daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are
                  allowed).

          -  Subjects must have completed the primary thoracic CRT at least 4 weeks (28 days) and
             no later than 12 weeks (84 days) prior to randomization. Subjects who received
             prophylactic brain irradiation as part of primary CRT are eligible.

          -  Documented stable disease or objective response, according to Response Evaluation
             Criteria in Solid Tumors (RECIST) 1.1, after primary concurrent CRT for unresectable
             stage III disease, within 4 weeks (28 days) prior to randomization

          -  An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  A platelet count, white blood cells (WBC) and hemoglobin value as defined in the
             protocol

          -  Male or female, greater than or equal to 18 years of age

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Undergone lung cancer specific therapy (including surgery) other than initial
             concurrent CRT

          -  Received chemotherapy during radiotherapy in radiosensitizing doses only (e.g., daily
             low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).

          -  Metastatic disease

          -  Malignant pleural effusion at initial diagnosis, during initial CRT, 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

          -  A recognized immunodeficiency disease including human immunodeficiency virus (HIV)
             infection and other cellular immunodeficiencies, hypogammaglobulinemia or
             dysgammaglobulinemia; subjects who have hereditary, congenital or acquired
             immunodeficiencies

          -  Splenectomy

          -  Any preexisting medical condition requiring chronic systemic steroid or
             immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are
             allowed)

          -  Receipt of immunotherapy (as defined in the protocol) within 4 weeks prior to
             randomization

          -  Receipt of investigational systemic drugs (including off-label use of approved
             products) within 4 weeks prior to randomization

          -  Autoimmune disease

          -  Active or chronic infectious hepatitis

          -  Infectious process that, in the opinion of the Investigator, could compromise the
             subject's ability to mount an immune response

          -  Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as
             defined in the protocol

          -  Pregnant or breast-feeding women

          -  Known drug abuse/alcohol abuse

          -  Participation in another interventional clinical trial within the past 28 days
             (excluding purely observational studies)

          -  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

          -  Other protocol defined exclusion criteria could apply