Abstract 137P
Background
Recently, multiple clinical trials demonstrated neoadjuvant chemoimmunotherapy is a promising treatment option for resectable non-small-cell lung cancer (NSCLC). However, there is still limited evidence for using chemoimmunotherapy as neoadjuvant treatment in potentially resectable stage III squamous NSCLC. TACT (NCT05024266) is a phase II, open label, single arm trial evaluating the efficacy and safety of tislelizumab(Tis) plus chemotherapy(CT) as neoadjuvant treatment for potentially resectable stage IIIA-IIIB(N2) squamous NSCLC.
Methods
Treatment-naive adults confirmed clinical stage IIIA-IIIB (AJCC 8th), potentially resectable squamous NSCLC and ECOG PS 0-1 were eligible. Patients(pts) intravenously received Tis (200mg d1) + Albumin-bound paclitaxel (260mg/m2 d1) + Carboplatin (AUC 5 d1), Q3W for 2-4 cycles before surgery and 0-2 cycles post surgery (totally 4 cycles). The primary endpoint was major pathological response (MPR) rate and safety. Secondary endpoints included pathologic complete response (pCR) rate, R0 resection rate, overall response rate (ORR), median disease-free survival (DFS) and median overall survival (OS). Exploratory endpoints included biomarkers analysis.
Results
Between September 13, 2021 and May 17, 2022, 35 pts (median age: 65, IQR: 48-78; male: 100%; stage IIIB disease:17%; TPS PD-L1≥1% (22C3): 67.9% ,19/28) were enrolled. After 2-4 cycles of neoadjuvant treatment, 32 pts underwent surgical resection and all of them achieved R0 resection. 23 pts (71.9%) achieved MPR (95% CI, 53.3-86.3) and 11 pts (34.4%) achieved pCR (95% CI, 18.6-53.2). 31 pts(96.9%) had pathological downstaging (95% CI, 83.8-99.9) and no major surgical complications were observed. ORR was 88.6% (95% CI,73.3-96.8). DFS and OS data was immature. One patient (2.9%) experienced grade 3 immune-related hepatitis. No grade 4-5 adverse events were reported.
Conclusions
Neoadjuvant Tis with CT was feasible and safe for pts with potentially resectable stage IIIA-IIIB(N2) squamous NSCLC. Ongoing analysis of predictive biomarker on efficacy and safety will be available in the future meeting.
Clinical trial identification
NCT05024266. First Posted: August 27, 2021.
Legal entity responsible for the study
Jianzhen Shan.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.