WCLC 2025 - Posters & ePosters-P3.18.21 Durvalumab (D) and Chemotherapy Followed by Either Surgery + D or Chemoradiotherapy + D in Borderline Resectable Stage III NSCLC

P3.18.21 Durvalumab (D) and Chemotherapy Followed by Either Surgery + D or Chemoradiotherapy + D in Borderline Resectable Stage III NSCLC

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This multicenter phase II study (ACCESS, NCT06998719) evaluates the efficacy and safety of neoadjuvant durvalumab combined with platinum-based chemotherapy in Chinese patients with borderline resectable stage III non-small cell lung cancer (NSCLC) that is EGFR and ALK wild type. Patients eligible for inclusion must have histologically or cytologically confirmed NSCLC, be treatment-naïve, borderline resectable as confirmed by multidisciplinary team (MDT) evaluation, and have ECOG performance status 0 or 1. Exclusion criteria include more than one primary tumor, prior or active autoimmune/inflammatory disorders, and history of certain malignancies within five years.<br /><br />The study aims primarily to assess resection rates following neoadjuvant durvalumab plus chemotherapy. Secondary objectives include rates of pathological complete response (pCR) in the resectable cohort, progression-free survival (PFS) in the unresectable cohort receiving chemoradiotherapy (CRT) and consolidation durvalumab, objective response rate (ORR), and event-free survival (EFS) across both cohorts.<br /><br />Patients receive neoadjuvant durvalumab every 4 weeks with platinum-based chemotherapy every 3 weeks (1-2 cycles) prior to restaging. Those deemed resectable proceed to surgery followed by adjuvant durvalumab for one year. Those unresectable receive definitive CRT plus consolidation durvalumab. Treatment efficacy and safety are monitored throughout, with a 3-month safety follow-up after completion.<br /><br />This study addresses the limited treatment data for borderline resectable stage III NSCLC, a heterogeneous group requiring tailored multimodal strategies. By integrating immunotherapy with chemotherapy and/or CRT, ACCESS explores a potentially improved treatment paradigm balancing curative intent surgery and non-surgical approaches guided by MDT evaluation. AstraZeneca China funded the trial, and no conflicts of interest were reported.

Asset Subtitle

Nan Bi

Meta Tag

Speaker Nan Bi

Topic Clinical Trials in Progress

Keywords

neoadjuvant durvalumab

platinum-based chemotherapy

borderline resectable stage III NSCLC

EGFR and ALK wild type

multicenter phase II study

pathological complete response (pCR)

progression-free survival (PFS)

chemoradiotherapy (CRT)

multidisciplinary team (MDT) evaluation

AstraZeneca China funded trial