Funding

This study was funded by AstraZeneca.

Conflicts of interest

Manish R. Patel: received honoraria from Adaptive Biotechnologies, Bayer, Genentech, Janssen Oncology, Pfizer, and Pharmacyclics; has been a consultant/advisor for Pharmacyclics/Janssen and Pfizer/EMD Serono; has been on the speakers bureau for Celgene, Exelixis, Genetech/Roche, and Taiho Pharmaceuticals; and received institutional research funding from Accutar Biotech, Acerta Pharma, Adagene, ADC Therapeutics, Agenus, Aileron Therapeutics, Artios, Astellas, AstraZeneca, BioNTech AG, BioTheryX, Black Diamond Therapeutics, Blueprint Pharmaceuticals, Boehringer Ingelheim, Celgene, Checkpoint Therapeutics, CicloMed, Clovis Oncology, Compugen, Cyteir Therapeutics, Daiichi Sankyo, EMD Serono, Evelo Therapeutics, FORMA Therapeutics, Genentech/Roche, Gilead Sciences, GlaxoSmithKline, H3 Biomedicine, Hengrui Therapeutics, Hutchison MediPharma, Ignyta, IgM Biosciences, Immunogen, Incyte, Jacobio, Janssen, Klus Pharma, Kymab, Lilly, Loxo, LSK Biopartners, Lycera, Mabspace, Macrogenics, Merck, Millenium, Mirati Therapeutics, Moderna Therapeutics, NGM Biopharmaceuticals, Novartis, Nurix, ORIC, Olema, Pfizer, Placon, Portola Pharmaceuticals, Prelude Therapeutics, Puretech, Relay Therapeutics, Ribon Therapeutics, Samumed, Seven and Eight Biopharmaceuticals, Silicon Therapeutics, Syndax, Taiho Pharmaceuticals, Takeda, TeneoBio, Tesaro, TopAlliance BioSciences Inc, Treadwell, Vigeo, and Zymeworks. Gerald S. Falchook: received royalties from Wolters Kluwer; has been an advisor for AbbVie, BostonGene, EMD Serono, Fujifilm, Inspirna, Jubilant, Merck, Navire, Predicine, Regeneron, Silicon, Teon, and Turning Point; has received speaker honorarium from Total Health Conferencing and Rocky Mountain Oncology Society; received reimbursement for travel from Amgen, Bristol-Myers Squibb, EMD Serono, Fujifilm, Millennium, Sarah Cannon Research Institute, and Synthorx/Sanofi; and received institutional research funding from 3-V Biosciences, Abbisko, AbbVie, ABL Bio ADC Therapeutics, Accutar, Aileron, American Society of Clinical Oncology, Amgen, ARMO/Eli Lilly, Artios, AstraZeneca, BeiGene, Bioatla, Bioinvent, Biothera, Bicycle, Black Diamond, Boehringer Ingelheim, Celldex, Celgene, Ciclomed, Curegenix, Curis, Cyteir, Daiichi, DelMar, eFFECTOR, Eli Lilly, EMD Serono, Epizyme, Erasca, Exelixis, Freenome, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, IGM Biosciences, Ignyta, ImmunoGen/MacroGenics, Incyte, Jacobio, Jounce, Jubilant, Kolltan, Loxo/Bayer, MedImmune, Millennium, Merck, miRNA Therapeutics, Molecular Templates, National Institutes of Health, Navire, NiKang, Novartis, OncoMed, Oncorus, Oncothyreon, Poseida, Precision Oncology, Prelude, PureTech, Pyramid, RasCal, Regeneron, Relay, Rgenix, Ribon, Samumed, Sapience, Seagen, Silicon, Simcha, Sirnaomics, Strategia, Syndax, Synthorx/Sanofi, Taiho, Takeda, Tarveda, Teneobio, Tesaro, Tocagen, Turning Point, U.T. MD Anderson Cancer Center, Vegenics, Xencor, and Zhuhai Yufan. Judy S. Wang: received honoraria for speaker bureau engagements from AstraZeneca; and received institutional funding from AstraZeneca to conduct this study. Esteban Rodrigo Imedio: at the time of the completion of this study, Esteban Rodrigo Imedio was an employee of AstraZeneca (no shares held). Sanjeev Kumar: employee of AstraZeneca; no shares held at the time of the completion of this study. Kowser Miah: employee of AstraZeneca and owns stocks/shares in the company. Ganesh M. Mugundu: at the time of the completion of this study, Ganesh M. Mugundu was an employee of AstraZeneca (no shares held). Suzanne F. Jones: has acted in a consulting/advisory role for Amgen and owns stock in HCA Healthcare. David R. Spigel: received institutional funding from AstraZeneca, Genentech/Roche, Novartis, Celgene, Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, AbbVie, Foundation Medicine, GlaxoSmithKline, Lilly, Merck, Moderna Therapeutics, Nektar, Takeda, Amgen, University of Texas Southwestern Medical Center – Simmons Cancer Center, G1 Therapeutics, Neon Therapeutics, Celldex, Clovis Oncology, Daiichi Sankyo, EMD Serono, Acerta Pharma, Oncogenex, Astellas Pharma, GRAIL, Transgene, Aeglea Biotherapeutics, Tesaro, Ipsen, ARMO BioSciences, and Millennium; consultation from AstraZeneca, TRM Oncology, Precision Oncology, Evelo Therapeutics, Illumina, PharmaMar, Genentech/Roche, Novartis, Celgene, Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, AbbVie, Foundation Medicine, GlaxoSmithKline, Lilly, and Merck; and travel and expenses from AstraZeneca, Genzyme, Intuitive Surgical, Purdue Pharma, Spectrum Pharmaceuticals, Sysmex, EMD Serono, Genentech/Roche, Novartis, Celgene, Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, AbbVie, Foundation Medicine, GlaxoSmithKline, Lilly, and Merck. Erika P. Hamilton: received institutional research funding from AbbVie, Acerta Pharma, Accutar Biotechnology, ADC Therapeutics, AKESOBIO Australia, Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond, Bliss BioPharmaceuticals, Boehringer Ingelheim, Cascadian Therapeutics, Clovis, Compugen, Context Therapeutics, Cullinan-Florentine, Curis, CytomX, Daiichi Sankyo, Dana Farber Cancer Institute, Dantari, Deciphera, Duality Biologics, eFFECTOR Therapeutics, Ellipses Pharma, Elucida Oncology, EMD Serono, FujiFilm, G1 Therapeutics, H3 Biomedicine, Harpoon, Hutchinson MediPharma, Immunogen, Immunomedics, Incyte, Infinity Pharmaceuticals, InventisBio, Jacobio, Karyopharm, K-Group Beta, Kind Pharmaceuticals, Leap Therapeutics, Lilly, Loxo Oncology, Lycera, Mabspace Biosciences, Macrogenics, MedImmune, Mersana, Merus, Millennium, Molecular Templates, Novartis, Nucana, Olema, OncoMed, Onconova Therapeutics, Oncothyreon, ORIC Pharmaceuticals, Orinove, Orum Therapeutics, Pfizer, PharmaMar, Pieris Pharmaceuticals, Pionyr Immunotherapeutics, Plexxikon, Prelude Therapeutics, Profound Bio, Radius Health, Regeneron, Relay Therapeutics, Repertoire Immune Medicine, Rgenix, Roche/Genentech, SeaGen, Sermonix Pharmaceuticals, Shattuck Labs, StemCentRx, Sutro, Syndax, Syros, Taiho, TapImmune, Tesaro, Tolmar, Torque Therapeutics, Treadwell Therapeutics, Verastem, Zenith Epigenetics, and Zymeworks; and has acted in a consulting/advisory role for Arcus, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Greenwich LifeSciences, iTeos, Janssen, Lilly, Loxo, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Pfizer, Relay Therapeutics, Roche/Genentech, SeaGen, Stemline Therapeutics, Theratechnologies, Tubulis, and Verascity Science.

Ethics approval and consent to participate

The study was approved by the institutional review board or independent ethics committee of each participating center and followed the Declaration of Helsinki and International Conference on Harmonisation Good Clinical Practice guidelines. All participants gave written informed consent.

Availability of data and material

Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Data for studies directly listed on Vivli can be requested through Vivli at www.vivli.org. Data for studies not listed on Vivli could be requested through Vivli at https://vivli.org/members/enquiries-about-studies-not-listed-on-the-vivli-platform/. AstraZeneca Vivli member page is also available outlining further details: https://vivli.org/ourmember/astrazeneca/.

Author Contributions

All authors made substantial contributions to the conception, design, acquisition, analysis, or interpretation of data for the manuscript. All authors have contributed to the development of this manuscript, approved the final version to be published, and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.