Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Carcinoma Tecemotide L-BLP25 Cyclophosphamide placebo controlled Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 285
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC) arm 2: Saline + Placebo + Best supportive care (BSC)

Interventions: intervention 1: Tecemotide intervention 2: Single low dose cyclophosphamide intervention 3: Placebo intervention 4: Saline intervention 5: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination. intervention 5: The BSC will be provided as per the investigator's discretion, and is not limited to palliative radiation, psychosocial support, analgesics and nutritional support.

Protocol document: