Funding

AstraZeneca.

Conflict of interest

Michael Maris: None. Gilles Salles: Financial compensation for participating in advisory boards or consulting from: Abbvie, BMS/Celgene, Debiopharm, Epizyme, Genentech/Roche, Incyte, Janssen, Kite/Gilead, Epizyme, Miltenyi, Morphosys, Novartis, VelosBio; and for participation in educational events from: Kite Pharma/Gilead Sciences. Won Seog Kim: Nothing to disclose. Tae Min Kim: Advisory or consultant roles for AstraZeneca, Novartis, Takeda, Sanofi, Roche/Genentech, and Boryung. Research funding from AstraZeneca and Korea Health Industry Development Institute outside this work. Roger Lyons: Consultancy and Advisory boards for ABBVie, Argenx, AstraZeneca, BriGene, Celgene, INCYTE, IQVIA, Karyopharm, Taiho, and Takeda. Martha Arellano: Advisory board member for Kite Pharma, Inc, Gilead Sciences, Inc, and Syndax Pharmaceuticals, Inc. Reem Karmali: Consulting Fees: Celgene Corporation, Gilead Sciences, Inc, Juno Therapeutics, Kite Pharma, OncLive, Verastem, Janssen, Karyopharm, Morphosys; Grants/Research; Support: Celgene Corporation, Juno Therapeutics, BMS, Takeda, BeiGene, AstraZeneca; Speakers Bureau: Celgene Corporation, Gilead Sciences, Inc, Juno Therapeutics, Kite Pharma, AstraZeneca, BeiGene, Morphosys. Gary Schiller: Stock and Other Ownership Interests: Bristol Myers Squibb, Amgen, Johnson & Johnson; Consulting or Advisory Role: Ono Pharmaceutical, Agios, Celgene, Incyte, Jazz Pharmaceuticals, Novartis, AbbVie, Astellas Pharma; Speakers' Bureau: Astellas Pharma, Kite, a Gilead Company, Jazz Pharmaceuticals, Stemline Therapeutics, Bristol Myers Squibb, Sanofi, Karyopharm Therapeutics, Incyte, AbbVie; Research Funding: AbbVie, Actinium Pharmaceuticals, Actuate Therapeutics, Arog, Astellas Pharma, Bristol Myers Squibb/Celgene, Celator, Constellation Pharmaceuticals, Daiichi Sankyo, Deciphera, Delta-Fly Pharma, FORMA Therapeutics, Fujifilm, Gamida Cell, Genentech/Roche, Geron, Incyte, Karyopharm Therapeutics, Kite, a Gilead Company, Mateon Therapeutics, Onconova Therapeutics, Pfizer, Precog, REGiMMUNE, Samus Therapeutics, Sangamo Bioscience, SELLAS Life Sciences, Stemline Therapeutics, Takeda, Tolero Pharmaceuticals, Trovagene, Agios, Amgen, Jazz Pharmaceuticals, ElevateBio, Ono Pharmaceutical, Novartis, Sanofi, AVM Biotechnology, Syros Pharmaceuticals. Elizabeth Cull: Speaker for Bristol Myers Squibb. Camille N. Abboud: Clinical research support from Novartis, Gilead, and Ryvu. Connie Batlevi: Research Funding: Janssen, Novartis, Epizyme, Xynomics, Bayer, Autolus, Roche; Consulting/Advisory Boards: Life Sci, GLG, Juno/Celgene, Seattle Genetics, Kite Pharma, Karyopharm, TG Therapeutics, ADC Therapeutics; Honorarium: Dava Oncology, TouchIME, Medscape; Stock ownership: BMS, Pfizer, Viatris, Regeneron, Moderna, Novavax. Ioannis Kagiampakis: Employee of AstraZeneca and may own stock or stock options. Marlon C. Rebelatto: Employee of AstraZeneca and may own stock or stock options. Young Lee: Employee of AstraZeneca and may own stock or stock options. Lyndon C. Kirby: Employee of AstraZeneca and may own stock or stock options. Fujun Wang: Employee of AstraZeneca and may own stock or stock options. Current equity holder in a publicly traded company. John Bothos: Employee of AstraZeneca and may own stock or stock options. Danielle M Townsley: Employee of AstraZeneca and may own stock or stock options. Amir T. Fathi: Consulting/Advisory Fees: Celgene/BMS, Foghorn, Kite Pharma, Morphosys, Abbvie, Agios, Genentech, Takeda, Pfizer, Trillium, Kura Oncology, Blueprint, Astellas; Grants/Research Support: Celgene/BMS, Abbvie, Agios. Vincent Ribrag: Advisory boards for Gilead, Infinity, MSD, BMS, Nanostring, Incyte, Roche, AstraZeneca, Servier; Research support from Argen-X and Astex.

Availability of data and material

Data underlying the findings described in this article may be obtained in accordance with AstraZeneca’s data-sharing policy, described at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Ethics approval

The study protocol was approved by an institutional review board or independent ethics committee at each study site. The study was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation/Good Clinical Practice.

Informed Consent

All patients provided written informed consent.

Author contributions

Investigators on the trial: MM, GS, WSK, TMK, RML, MA, RK, GS, EC, CAN, CB, ATF, VR. Members of the Steering Committee: MM. Provided clinical and scientific input to the study design and study protocol: MM, YL (design and protocol for TM exploratory biomarker analyses), MR (design and protocol for PD-L1 IHC assessment). Trial statistician: FW. Interpreted the data: YL, IK, MR, MM. TM contributors: IK, MR, YL. All authors had full access to the data and analyses and vouch for the accuracy and integrity, and for the fidelity of the study to the protocol. All authors were involved in review of each draft of the manuscript and the decision to submit.