Abstract 176TiP
Background
Neoadjuvant PD-1/PD-L1 inhibitors combined with chemotherapy are a standard approach for resectable non-small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements. However, the outcomes in EGFR-mutant NSCLC remain inconsistent. A retrospective study of neoadjuvant immunotherapy combined with chemotherapy in driver gene-positive patients reported a major pathological response (MPR) rate of 37.5% and a pathological complete response (pCR) rate of 12.5%. Subgroup analyses from the phase III KEYNOTE-671 and AEGEAN trials indicate potential benefit for EGFR-mutant patients, with the KEYNOTE-671 trial showing improved event-free survival (EFS), although pCR rates were modest in the AEGEAN trial. Adebrelimab, a novel anti-PD-L1 monoclonal antibody, demonstrated a high MPR rate in a phase Ib study in patients with resectable stage II–III NSCLC without driver mutations, along with manageable toxicity profiles. Based on these findings, we aim to evaluate perioperative adebrelimab combined with chemotherapy in patients with resectable EGFR-mutant NSCLC.
Trial design
This is a multicenter, single-arm, phase II study. Eligible patients must have resectable stage II–IIIB NSCLC with EGFR mutations. Thirty-six patients will receive adebrelimab, albumin-bound paclitaxel, and carboplatin or cisplatin for three 21-day cycles of neoadjuvant treatment before surgery, followed by one cycle post-surgery and then investigator-choice adjuvant therapy. The primary endpoint is the rate of pCR. Secondary endpoints include MPR, objective response rate (ORR), EFS, overall survival (OS), and safety. Additional exploratory analyses will include whole exome sequencing (WES), whole transcriptome sequencing (WTS), and minimal residual disease (MRD) detection to assess the relationship between molecular biomarkers and clinical outcomes.
Clinical trial identification
NCT06299371.
Legal entity responsible for the study
Liaoning cancer hospital & institute.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.