Merck KGaA 2015

Trial name or title	Study of tecemotide (l‐blp25) in participants with stage III unresectable non‐small cell lung cancer (NSCLC) following primary chemoradiotherapy
Methods	Japanese RCT, Phrase I/II
Participants	Number of participants: 172 (December 2008 to June 2015) Number randomised: Experimental group (Tecemotide (L‐BLP25) + cyclophosphamide):114 Control group (placebo + saline control): 58 Number evaluated: Experimental group: not specified Control group: not specified Diagnosis: patients with locally advanced unresectable stage III NSCLC Inclusion: The eligibility criteria are as follows: ≥ 20 years of age; receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum‐based chemotherapy and a minimum radiation dose of greater than or equal to (≥) 50 Gray (Gy); histologically or cytologically documented unresectable stage III NSCLC. Cancer stage must be confirmed and documented by Computed Tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scan; documented stable disease or objective response, according to RECIST, after primary chemoradiotherapy for unresectable stage III disease, within four weeks prior to randomisation; receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum‐based chemotherapy and a minimum radiation dose of ≥ 50 Gy; Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1; adequate bone marrow function
Interventions	Experimental group: Tecemotide (L‐BLP25) + Cyclophosphamide Control group: Placebo + Saline
Outcomes	Overall survival
Starting date	December 2008
Contact information
Notes	This study has been completed, but no publication was found at the time of literature searching