2153 - CRUISER: A Phase 2 Trial of Concurrent durvalumab with Chemoradiation Therapy Followed by durvalumab in Chinese Unresectable Stage III Non-Small Cell Lung Cancer Patients

F. Teng¹, H. Ge², B. Wang³, Y. Xu⁴, X. Meng⁵, L. Xing⁶, T. Yin¹, and J. Yu⁷; ¹Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China, ²Department of Radiation Oncology, Henan Cancer Hospital, Zhengzhou, Henan, China, ³Department of Oncology, Northern Jiangsu Peoples Hospital, Yangzhou, China, ⁴Shanghai Pulmonary Hospital, Shanghai, China, ⁵Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China, ⁶Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China, ⁷Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China

Purpose/Objective(s): Concurrent chemoradiation therapy (CRT) followed by durvalumab had demonstrated significant survival benefit for unresectable stage III (USIII) non-small cell lung cancer (NSCLC) patients (pts) in PACIFIC trial. However, 20%-30% pts have no chance to receive immunotherapy due to disease progression (PD) or intolerable toxicity during CRT period. This prospective study aimed to evaluate safety and efficacy of concurrent durvalumab with CRT followed by durvalumab in USIII NSCLC. Materials/

Methods: CRUISER is a multi-center phase 2 study with USIII NSCLC. All pts will receive concurrent durvalumab and CRT followed by durvalumab until PD or unacceptable toxicity. Optional induction therapy with one cycle is allowed upon investigators’ decisions. The primary endpoint was the incidence of =3 grade immune-mediated adverse event (imAE). Second endpoints were progression free survival (PFS) according to RECIST 1.1, overall survival (OS), and objective response rate (ORR).
Results: Between Jan 2021 and Sep 2022, 35 pts from 4 hospitals were enrolled. Median age was 64 years, 85.7% were male, and 54.3% were squamous carcinoma. IIIA/ /IIIB /IIIC NSCLC accounted for 34.3% (12/35), 48.6% (17/35), and 17.1% (6/35), with most of them (91.4%, 32/35) having N2/N3 metastases. Among the 20 (57.1%) pts received induction therapy, 17 pts received durvalumab plus chemotherapy. The median total dose of radiotherapy was 60 Gy. As of December 8^th, 2023, Grade =3 imAE occurred in 4(11.4%) of 35 pts. With median follow-up of 19.0 months (m), median PFS was 14.4m (95% CI 10.2, NE), and one-year PFS rate was 60.9%. A trend of better one-year PFS rate was observed in subsets with induction therapy than without (68.8% vs 50.5%), received>one cycle concurrent chemoradiation than one cycle (64.3% vs 51.8%) and received durvalumab with =seven cycles than
Conclusion: Concurrent durvalumab with CRT followed by durvalumab for USIII NSCLC is tolerable. Radiotherapy with induction therapy and more cycles of concurrent chemoradiation and durvalumab demonstrates better outcome via this treatment regimen.