Katakami 2017.

Study characteristics
Methods	Japan; multicentre (25 centres); RCT; phase I/II
Participants	Number of participants: 172  Number randomised Experimental group (tecemotide (L‐BLP25) + cyclophosphamide): 114 Control group (placebo + saline): 58 Number evaluated Experimental group: 114, median age (range): 62.0 (33 to 86) years Control group: 58, median age (range): 63.0 (36 to 81) years Diagnosis: unresectable stage III NSCLC, stable disease or clinical response after primary chemoradiotherapy and performance status ≤ 1 Inclusion: eligible participants:  patients aged ≥ 20 years with unresectable histologically or cytologically documented stage III NSCLC, with stable disease or clinical response (Response Evaluation Criteria In Solid Tumors; RECIST version 1.0) after primary chemoradiotherapy (≥ 2 cycles of platinum‐based chemotherapy plus ≥ 50 Gy concurrent or sequential thoracic radiotherapy) white blood cell count ≥ 2500/mm3 (2.5 × 109/L), haemoglobin ≥ 9.0 g/dL (90 g/L), and platelet count ≥ 140,000/mm3 (140 × 109/L), and ECOG performance status ≤ 1 were recruited
Interventions	Experimental group: tecemotide (930 ug as lipopeptide) subcutaneously once weekly for 8 weeks, then every 6 weeks until disease progression or treatment withdrawal. Cyclophosphamide 300 mg/m2 (maximum dose 600 mg) was given intravenously 3 days before the first dose of tecemotide.  Control group: placebo subcutaneously once weekly for 8 weeks, then every 6 weeks until disease progression or treatment withdrawal.
Outcomes	Duration of follow‐up: 34 weeks Overall survival Progression–free survival Time to progression Time to treatment failure Safety
Notes	The work was supported by Merck Serono Co Ltd, Tokyo, Japan. The sponsor, Merck Serono Co Ltd, Tokyo, Japan, as well its parent company, Merck KGaA, Darmstadt, Germany, worked with the investigators to develop the study design, carry out the analysis and interpretation of the study data, and contributed through critical review to the writing of this report, and supported the authors in the submission.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The author reported “Central randomisation”, but the method for randomisation number generation was not described.
Allocation concealment (selection bias)	Low risk	Quote: “Central randomisation and treatment allocation in the phase II part was performed.”
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "This was a multicenter (25 centers), randomized, double‐blind and placebo‐controlled trial, conducted in accordance with the Declaration of Helsinki and in compliance with Good Clinical Practice."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	155 participants (90.1%) were included in the analysis.
Selective reporting (reporting bias)	Low risk	The prior protocol was available. No selective reporting of a particular outcome measurement or a particular outcome. Efficacy analysis was performed in three sets: ITT, mITT, and safety sets.
Other bias	Low risk	No obvious potential source of bias.