79P - A prospective, single-arm, phase II study to evaluate the efficacy and safety of Tislelizumab plus chemotherapy in resectable NSCLC

Background

Perioperative immunotherapy has been shown to be promising option for resectable non-small cell lung cancer(NSCLC). This study aimed to investigate the efficacy and safety of perioperative treatment with tislelizumab (PD-1 inhibitor) plus chemotherapy in resectable stage II-III NSCLC.

Methods

This open-label, single-arm, phase 2 trial planned to enroll 20 patients(pts) with resectable II-IIIB(N2) (AJCC 8th) NSCLC. Pts received neoadjuvant treatment with intravenous tislelizumab combined with chemotherapy Q3W for 2-3 cycles before surgery and 1-2 cycles after surgery (up to 4 cycles perioperative chemotherapy), followed by tislelizumab Q3W for 1 year. Primary endpoints were major pathological response (MPR) rate, the secondary endpoints included pathologic complete response (pCR) rate, objective response rate (ORR), event-free survival (EFS) and overall survival (OS). This study is registered with chictr.org.cn, ChiCTR2300068140.

Results

Between February 2023 and August 2023, 15 pts (median age: 67; male:80%) were enrolled, of whom 66.7% pts had stage III disease, 93.3% pts had squamous cell lung cancer. Among 15 enrolled pts, 5 pts are on neoadjuvant period; 10 pts completed neoadjuvant treatment, and 9 of them underwent surgery with 100% R0 resection. Of 9 pts who underwent resection, 5 pts (55.6%) achieved MPR and pCR. ORR was 63.6%, DFS and OS data was immature. The most common TRAEs were anemia (n=8; 53.3%), and thrombocytopenia (n =5; 33.3%). Most of the TRAEs were grade 1or 2. 3 pts experienced Grade 3 TRAE of WBC count decreased, increased creatine kinase and pneumonia, respectively. No grade 4-5 adverse events were reported.

Conclusions

Tislelizumab combined platinum-based chemotherapy demonstrated high MPR and pCR rate, feasible surgical resection and manageable toxicity in stage II-IIIB NSCLC. Pts will be followed for long-term survival.

Clinical trial identification

ChiCTR2300068140.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.