Abstract 175TiP
Background
The integration of PD-1/PD-L1 inhibitors into the perioperative management of patients with early and locally advanced NSCLC has led to significant improvements in event-free survival (EFS) and has become a standard of care. However, the optimal schedule and duration of PD-1/PD-L1 inhibitor treatment is unclear, as current data demonstrate significant EFS benefits across neoadjuvant, adjuvant, or perioperative settings. Notably, the value of adding adjuvant immunotherapy after neoadjuvant chemo-immunotherapy remains to be prospectively evaluated and potentially tailored to specific patient subgroups.
Trial design
ADOPT-lung is a randomised, multicentre, phase III trial assessing the impact of the adjuvant component of perioperative chemoimmunotherapy with durvalumab on disease-free survival (DFS) in patients with completely resected stage IIB-IIIB (N2) NSCLC. Treatment consists of 3–4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with complete resection (R0 and R1) will be randomised to receive either 12 cycles of adjuvant durvalumab or observation. Patients with positive margins (R1) should also receive radiotherapy as per local guidelines. The primary endpoint is DFS in patients without pathological complete response (non-pCR), measured from randomisation; key secondary endpoint (hierarchically tested) is DFS in the intention-to-treat (ITT) cohort; other secondary endpoints include DFS in patients with pCR and OS in patients with/without pCR, as well as in the ITT cohort. A total of 520 patients will be enrolled to have sufficient power to evaluate DFS in non-pCR randomised NSCLC patients. Stratification factors are pathological response (pCR vs non-pCR), histology (squamous vs non-squamous), stage (IIB vs III) and PD-L1 (
Clinical trial identification
NCT06284317.
Legal entity responsible for the study
ETOP IBCSG Partners Foundation.
Funding
AstraZeneca.
Disclosure
S. Schmid: Financial Interests, Institutional, Invited Speaker: AstraZeneca, Sanofi, Janssen; Financial Interests, Institutional, Advisory Board: AstraZeneca, BMS, MSD, Merck, Janssen, Roche, Pfizer; Financial Interests, Personal, Other, Travel support: Roche; Financial Interests, Personal, Other, Travel support: Amgen; Financial Interests, Institutional, Invited Speaker, supporting Co-PI: Regeneron; Financial Interests, Institutional, Invited Speaker, Co Trial Chair: AstraZeneca. G. Dimopoulou: Financial Interests, Institutional, Full or part-time Employment, Institutional financial support from for biostatistician contribution: Frontier Science Foundation-Hellas. P.E. van Schil: Financial Interests, Institutional, Advisory Board, external expert: AstraZeneca, Janssen; Financial Interests, Personal, Advisory Board, external expert: MSD, Roche, BMS; Financial Interests, Personal, Member of Board of Directors, President IASLC 2023–2025: IASLC. S.P. Finn: Financial Interests, Personal, Invited Speaker: AstraZeneca, Takeda; Financial Interests, Personal, Advisory Board: Illumina, Amgen, Pfizer; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Personal, Stocks/Shares: Revolution Medicines. B. Solomon: Financial Interests, Institutional, Advisory Board: AstraZeneca, Novartis, Merck, Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker: Pfizer, Novartis; Financial Interests, Personal, Advisory Board: Amgen, Roche-Genentech, Eli Lilly, Takeda, Janssen; Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche/Genentech; Financial Interests, Personal, Full or part-time Employment, Employed as a consultant Medical Oncologist at Peter MacCallum Cancer Centre: Peter MacCallum Cancer Centre; Financial Interests, Personal, Member of Board of Directors: Cancer Council of Victoria, Thoracic Oncology Group of Australasia; Financial Interests, Personal, Royalties: UpToDate; Financial Interests, Institutional, Invited Speaker, Principal Investigator and Steering committee Chair: Roche/Genentech, Pfizer. S. Popat: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Novartis, Amgen, Janssen, Daiichi Sankyo, AstraZeneca, Bayer, BMS, Blueprint, Guardant Health, Takeda, Lilly, Turning Point Therapeutics, GSK, MSD, Pfizer, Sanofi, EQRx, AnHeart, Arcus Biosciences, Ellipses, Gilead, IO Biotech, Mirati; Financial Interests, Personal, Expert Testimony: Merck Serono, Roche; Financial Interests, Personal, Invited Speaker: Medscape, VJ Oncology, Novocure, PharmaMar; Financial Interests, Institutional, Other, Subinvestigator: Amgen; Financial Interests, Institutional, Invited Speaker: Ariad, AstraZeneca, Roche, Boehringer Ingelheim, Celgene, Daiichi Sankyo, GSK, Takeda, Trizel, Turning Point Therapeutics, Roche, Janssen, BMS, Lilly; Financial Interests, Institutional, Other, Sub-Investigator: MSD, Blueprint; Financial Interests, Institutional, Research Grant: Guardant Health; Non-Financial Interests, Personal, Leadership Role, Chair of Steering Committee, Unpaid: British Thoracic Oncology Group; Non-Financial Interests, Personal, Officer, Thoracic Faculty, Unpaid: European Society of Medical Oncology; Non-Financial Interests, Personal, Leadership Role, Foundation Council Member, Unpaid: European Thoracic Oncology Platform; Non-Financial Interests, Personal, Advisory Role, Mesothelioma Committee, Unpaid: International Association for the Study of Lung Cancer; Non-Financial Interests, Personal, Member of Board of Directors, Unpaid: Mesothelioma Applied Research Foundation; Non-Financial Interests, Personal, Advisory Role, Honorary Clinical Advisor, Unpaid: ALK Positive UK; Non-Financial Interests, Personal, Advisory Role, Research Advisory Group Member, Unpaid: Ruth Strauss Foundation; Non-Financial Interests, Personal, Advisory Role, Scientific Adivsory Board Member, Unpaid: Lung Cancer Europe. M. Pérol: Financial Interests, Personal, Advisory Board, Advisory board: Roche, AstraZeneca, MSD, BMS, Lilly, Novartis, Takeda, Gritstone, Sanofi, Pfizer, Amgen, Janssen, GSK, Esai, Ipsen, Novocure, AbbVie, Anheart Therapeutics, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker, Symposium: Roche, AstraZeneca, MSD, BMS, Boehringer Ingelheim, Takeda, Illumina, Pfizer, Medscape; Financial Interests, Personal, Expert Testimony, Expert Testimony: AstraZeneca; Financial Interests, Personal, Invited Speaker, Steering Committee member: Lilly; Financial Interests, Institutional, Invited Speaker, Local PI: AbbVie, Amgen, Anheart Therapeutics, Apollomics, Arrivent Biopharma, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Innate Pharma, Roche; Financial Interests, Institutional, Research Grant, Resarch grant: AstraZeneca, Boehringer Ingelheim, Roche, Takeda; Financial Interests, Personal, Invited Speaker, Trial Chair: Anheart Therapeutics; Financial Interests, Personal, Invited Speaker, IDMC Chair: PharmaMar, Sophiagenetics; Financial Interests, Personal, Invited Speaker, Steering Committee Member: Roche; Financial Interests, Personal, Other, DMSB: Roche. L. Landi: Financial Interests, Personal, Advisory Board: Roche, Pfizer, Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson; Financial Interests, Personal, Invited Speaker: Roche, Pfizer, Amgen, AstraZeneca, Eli Lilly, Novartis, Sanofi; Financial Interests, Personal, Other, Consultant: MSD; Financial Interests, Personal, Other, consultant: BMS, AbbVie. K. Oselin: Financial Interests, Personal, Advisory Board: MSD, Takeda, Roche; Financial Interests, Institutional, Research Grant: Takeda, Pfizer, Optellum. C. Aigner: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Biotest, Chiesi, Ewimed; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Atricure; Financial Interests, Institutional, Invited Speaker: BMS, PharmaCept. U. Dafni: Financial Interests, Personal, Other, Member of the Tumor Agnostic Evidence Generation working Group: Roche; Financial Interests, Personal, Expert Testimony, Statistical review and assessment of a Clinical Trial: AstraZeneca; Non-Financial Interests, Personal, Leadership Role, Member of the BoD & Manager of this not for profit organization providing statistical expertise and support in Clinical trials, primarily in cancer: Frontier Science Foundation - Hellas. R.A. Stahel: Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, Novocure, PharmaMar; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Other, Co-Editor in Chief: Lung Cancer; Financial Interests, Personal, Other, Editor: CTR; Financial Interests, Institutional, Research Grant, ETOP study: Roche, AstraZeneca, BMS, MSD, Pfizer, Mirati, Janssen, Amgen, GSK; Financial Interests, Institutional, Research Grant, IBCSG study: Novartis, Ipsen, Pierre Fabre, MSD, Pfizer, Roche, AstraZeneca, Celgene; Non-Financial Interests, Personal, Member of Board of Directors, President Foundation Council: ETOP IBCSG Partners Foundation. S. Peters: Financial Interests, Institutional, Advisory Board: Vaccibody, Takeda, Seattle Genetics, Sanofi, Roche/Genentech, Regeneron, Phosplatin Therapeutics, PharmaMar, Pfizer, Novartis, Mirati, Merck Serono, MSD, Janssen, Incyte, Illumina, IQVIA, GSK, Gilead, Genzyme, Foundation Medicine, F-Star, Eli Lilly, Debiopharm, Daiichi Sankyo, Boehringer Ingelheim, Blueprint Medicines, Biocartis, Bio Invent, BeiGene, Bayer, BMS, AstraZeneca, Arcus, Amgen, AbbVie, iTheos, Novocure; Financial Interests, Institutional, Invited Speaker: Takeda, Sanofi, Roche/Genentech, RTP, Pfizer, PRIME, PER, Novartis, Medscape, MSD, Imedex, Illumina, Fishawack, Eli Lilly, Ecancer, Boehringer Ingelheim, BMS, AstraZeneca, OncologyEducation, RMEI, Mirati; Financial Interests, Personal, Other, Associate Editor Annals of Oncology and Deputy Editor Lung Cancer: Elsevier; Financial Interests, Institutional, Advisory Board, Permanent independent scientific advisor: Hutchmed; Financial Interests, Institutional, Member of Board of Directors, Swiss network of pharmacies: Galenica; Financial Interests, Institutional, Invited Speaker, MERMAID-1: AstraZeneca; Financial Interests, Institutional, Invited Speaker, MERMAID-2, POSEIDON, MYSTIC: AstraZeneca; Financial Interests, Institutional, Invited Speaker, Clinical Trial Steering committee CheckMate 743, CheckMate 73L, CheckMate 331 and 451: BMS; Financial Interests, Institutional, Invited Speaker, RELATIVITY 095: BMS; Financial Interests, Institutional, Invited Speaker, BGB-A317-A1217-301/AdvanTIG-301: BeiGene; Financial Interests, Institutional, Invited Speaker, Clinical Trial Chair ZEAL-1: GSK; Financial Interests, Institutional, Invited Speaker, Clinical Trial steering Committee PEARLS, MK-7684A: MSD; Financial Interests, Institutional, Invited Speaker, Clinical Trial Steering Committee SAPPHIRE: Mirati; Financial Interests, Institutional, Invited Speaker, LAGOON: PharmaMar; Financial Interests, Institutional, Invited Speaker, phase 1/2 trials: Phosplatin Therapeutics; Financial Interests, Institutional, Invited Speaker, Clinical Trial Chair Skyscraper-01; chair ALEX; steering committee BFAST; steering committee BEAT-Meso; steering committee ImPower-030, IMforte: Roche/Genentech; Financial Interests, Institutional, Invited Speaker, Phase 2 Inupadenant with chemo: iTeos; Non-Financial Interests, Personal, Officer, ESMO President 2020–2022: ESMO; Non-Financial Interests, Personal, Officer, Council Member & Scientific Committee Chair: ETOP/IBCSG Partners; Non-Financial Interests, Personal, Officer, Vice-President Lung Group: SAKK; Non-Financial Interests, Personal, Other, Involved in Swiss politics: Swiss Political Activities; Non-Financial Interests, Personal, Officer, President and Council Member: Ballet Béjart Lausanne Foundation; Non-Financial Interests, Personal, Principal Investigator, Involved in academic trials: ETOP /EORTC / SAKK; Non-Financial Interests, Personal, Member: Association of Swiss Physicians FMH (CH), ASCO, AACR, IASLC; Non-Financial Interests, Personal, Leadership Role, ESMO President: ESMO; Non-Financial Interests, Personal, Member, Vice-President Lung Group: SAKK; Non-Financial Interests, Personal, Leadership Role, Vice -President: SAMO; Non-Financial Interests, Personal, Member, Association of Swiss interns and residents: ASMAC/VSAO. All other authors have declared no conflicts of interest.