LAUSR

s Annals of Oncology continue per protocol. Treatment with pembrolizumab/placebo will continue for up to 35 administrations (w2 years) or until disease progression, unacceptable toxicity, intercurrent illness that prevents further administration of treatment, or noncompliance. Patients will be stratified by geographic region (Europe/Israel/North America/ Australia vs Asia vs rest of world), PD-L1 tumor expression status (combined positive score <1 vs 1), and combination chemotherapy (FP vs CAPOX). Imaging will be performed Q6W, and adverse events (AEs) will be monitored throughout the study and for 30 days after treatment (90 days for serious AEs). The dual primary end points are OS and PFS per RECIST v1.1 as assessed by blinded independent central review (BICR). Secondary end points include ORR and DOR per RECIST v1.1 as assessed by BICR and safety. Enrollment is ongoing. Clinical trial identification: NCT03675737. Legal entity responsible for the study:Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding: Funding for this study was provided by Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Disclosure: J. Tabernero: Advisory/Consultancy: Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Inc., Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Part. E. van Cutsem: Advisory/Consultancy: Bayer, Lilly, Roche, Servier, BMS, Celegene, MSD, Merck KGaA, Novartis, AstraZeneca, Halozyme, Array BioPharma; Research grant/Funding (institution): Amgen, Bayer, Boehringer Ingelheim, Lilly, Novartis, Roche, Celegene, Ipsen, Merck, Merck KGaA, Servier, BMS. C.S. Fuchs: Advisory/Consultancy: Agios, Amylin Pharmaceuticals, Bain Capital, CytomX Therapeutics, Daiichi-Sankyo, Eli Lilly, Entrinsic Health, Evolveimmune Therapeutics, Genentech, Merck, Taiho, Unum Therapeutics; Leadership role: CytomX Therapeutics (director), Evolveimmune Therapeutics (co-founder); Shareholder/Stockholder/Stock options: CytomX Therapeutics and Entrinsic Health excised options; Evolveimmune Therapeutics. Y.Y. Janjigian: Advisory/ Consultancy: Lilly, Pfizer, Merck, Bristol-Myers Squibb, Merck Serono; Research grant/Funding (self): Boehringer Ingelheim, Bayer, Lilly, Amgen, Roche, Genentech. P. Bhagia: Full/Part-time employment: Merck & Co., Inc. K. Li: Full/Part-time employment: Merck & Co., Inc. D. Adelberg: Full/Part-time employment: Merck & Co., Inc. Y-J. Bang: Advisory/Consultancy: AstraZeneca, Novartis, Genentech/ Roche, MSD, Merck Serano, Bayer, BMS, Eli Lilly, Taiho, Daiich-Sankyo, Astellas, BeiGene, GreenCross, Samyang Biopharm, Hanmi, Genexine; Research grant/Funding (institution): AstraZeneca, Novartis, Genentech/Roche, MSD, Merck Serano, Bayer, BMS, GSK, Pfizer, Eli Lilly, Boeringer-Ingelheim, MacroGenics, Boston Biomedical, FivePrime, Curis, Taiho, Takeda, Ono, Daiichi Sankyo, Astellas, BeiGene, Green Cross, CKD Pharma, Genexi. All other authors have declared no conflicts of interest. https://doi.org/10.1016/j.annonc.2020.10.461