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Article History

Received: 26 April 2020

Revised: 26 November 2020

Accepted: 10 December 2020

First Online: 24 March 2021

Ethics approval and consent to participate

: The study was conducted according to the principles of the Declaration of Helsinki and the ICH Guidelines for Good Clinical Practice. The protocol was conducted under EU directive 2001/20/EC and approved by the Ethics Committee of the Medical University of Vienna, Borschkegasse 8b/6, A-1090 Vienna, Austria, as the leading ethics committee. All subjects provided their written informed consent to participate in the study.

: Not applicable.

: As the regulatory sponsor of this trial, ABCSG has data sovereignty and individual participant data (including de-identified participant data, participant data with identifiers, data dictionary or other specified datasets) will not be shared.

: R.B. reports advisory roles at AstraZeneca, Celgene, Daiichi, Eisai, Eli-Lilly, MSD, Novartis, Pfizer, Pierre-Fabre, Puma, Roche, Samsung, lecture honoraria: Accord, AstraZeneca, BMS, Celgene, Eli-Lilly, Novartis, Pfizer, Pierre-Fabre, Roche, Sandoz and received research support from Daiichi, Novartis and Roche, all outside of the submitted work. M.H. reports honoraria and/or travel support from Amgen, AstraZeneca, Celgene, Eli-Lilly, Pfizer, Novartis, Roche all outside the submitted work. A.L.P. reports honoraria and/or travel support from Abbvie, Amgen, AstraZeneca, Bayer, Celgene, Gilead, Janssen, Eli-Lilly, MSD, Pfizer, Novartis, Roche, Sanofi and Takeda all outside the submitted work. D.E. reports honoraria/travel support from Amgen, AstraZeneca, Celgene, Eli-Lilly, MSD, Novartis, Pfizer, Roche and Myriad all outside of the submitted work. M.F. has received honoraria for advisory boards from AstraZeneca, Bayer, Biomedica, Boehringer Ingelheim, Eli-Lilly, Merck Sharp & Dohme, Myriad Genetics Inc., Pfizer and Roche. M.G. reports personal fees/travel support from Amgen, AstraZeneca, Celgene, Eli-Lilly, Invectys, Pfizer, Novartis, Puma, Nanostring, Roche, Medison, LifeBrain, all outside the submitted work; an immediate family member is employed by Sandoz. Z.B.-H. has advisory roles at Biomedica, Roche and Novartis, received lecture honoraria and travel support from Roche and research support from Boehringer Ingelheim. C.F.S., G.P., H.S., A.P., E.P., V.B.-R., R.G., M.R., M.K.T., V.W., P.S., P.D., F.F., R.E., R.J., M.B., C.T. and S.F. declare no competing interests.

: This study was supported by Merck KGaA, Darmstadt, Germany. The academic non-profit organisation ABCSG was the regulatory sponsor of this trial. Merck provided financial funding and tecemotide. The study was designed and conducted by ABCSG. Merck was not involved in the collection, management, analysis and interpretation of the data. ABCSG prepared and approved the paper and decided to submit the paper for the publication.