Vansteenkiste 2013

Methods	International RCT (41 investigation sites in 12 European countries), Phase II
Participants	Number of participants: 182 (September 2005 to June 2010) Number randomised: Experimental group (MAGE‐A3 protein):122 Control group (Placebo): 60 Number evaluated: Experimental group: 122, age (mean and range): 63 (46 to 78) years Control group: 60, age (mean and range): 62.5 (45 to 81) years Diagnosis: Patients with completely resected MAGE‐A3–positive TNM Stage IB or II NSCLC Inclusion: eligible patients should: Be at least 18 years of age at the time of resection. Be completely resected and pathologically confirmed MAGE‐A3–positive stage IB or II NSCLC. Resection had to be anatomic and had to include at least a lobectomy. Patients were to have recovered (performance status 0 to 1) from surgery that had taken place no more than 8 weeks earlier and to have adequate bone marrow reserve and hepatic and renal functions.
Interventions	Experimental group: MAGE‐A3 protein + GlaxoSmithKline’s proprietary immunostimulant AS02B was administered intramuscularly in 0.5 mL doses. First administration was 4 to 8 weeks after resection, five doses at 3‐week intervals, followed by eight doses at 3‐month intervals. Control group: Placebo was sucrose in the tocopherol oil‐in‐water emulsion‐based adjuvant AS03A, was administered intramuscularly in 0.5 mL doses. First administration was 4 to 8 weeks after resection, five doses at 3‐week intervals followed by eight doses at 3‐month intervals.
Outcomes	Duration of follow‐up (median): participants were followed for 7.3 years, with a median of 70 months after resection. Disease‐free interval (DFI), OS, disease‐free survival (DFS), safety
Notes	Sponsor: Vincent G. Brichard The sponsor was involved in the study design, data collection, and analysis.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A supply randomisation list was generated at GSK Biologicals, Rixensart, using a standard SAS program and used to identify uniquely each individual vaccine dose (= treatment box). A randomisation blocking scheme (2:1 ratio) was used to ensure that balance between treatments was maintained.
Allocation concealment (selection bias)	Low risk	The person in charge of the vaccination accessed the randomisation system via the Internet. The randomisation system determined the treatment randomised and provided the treatment box number to be used for the first vaccination of this patient.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind, placebo‐controlled trial
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"scans were evaluated by the investigator or a radiologist blinded to the treatment assignment"
Incomplete outcome data (attrition bias) All outcomes	Low risk	182 participants included in the analysis (100%)
Selective reporting (reporting bias)	Low risk	Prior protocol was available.
Other bias	Low risk	No obvious potential source of bias