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

Ancillary Trial: An exploratory investigation of immune response in peripheral blood after
tecemotide (L-BLP25) or placebo vaccination.

The ancillary study is a sub-study within START. This is an exploratory investigation of the
immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination. The
main objective is to evaluate whether administration of single-shot, low-dose
cyclophosphamide followed by tecemotide (L-BLP25) vaccinations induces specific immune
response in peripheral blood to BLP25 (the mucinous glycoprotein 1 [MUC1] antigen) as well
as a modulation of cellular and soluble components of the immune response in subjects with
unresectable stage III NSCLC.

Twenty-five of the European START sites will participate in the ancillary study.

Sample size: up to 60 to 80 subjects

All inclusion criteria specified in the START clinical trial protocol except for hemoglobin
>= 100 gram/Liter (g/L)

All exclusion criteria are the same as specified in the START clinical trial protocol

Schedule of events: Blood samples will be taken at baseline, visit week 4, 8 13 and 25 (80
milliliter (mL) whole blood each)

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