Single-arm, multicentre phase II trial of sintilimab plus platinum-based doublet chemotherapy followed by adaptive radiotherapy strategy for patients with unresectable stage III non-small-cell lung cancer in China: the ART-LUNG 01 study protocol
Li Wu, Shuyun Ma, Xi Zhang, Zewen Song, Xuewen LiuIntroduction
Consolidation immunotherapy postchemoradiotherapy is standard for unresectable stage III non-small-cell lung cancer (NSCLC) per PACIFIC and GEMSTONE-301, but optimal integration with chemoradiotherapy is unclear, especially for large tumours. Induction immunotherapy before concurrent chemoradiotherapy (cCRT) may enhance tumour downstaging and immune synergy, while adaptive radiotherapy with strict lung constraints (V20 ≤20%) could reduce toxicity. This trial aims to evaluate the efficacy and safety of sintilimab with induction chemotherapy followed by adaptive radiotherapy and consolidation sintilimab in patients with unresectable stage III NSCLC.
Methods and analysis
This prospective, multicentre, single-arm phase II trial will enrol 35 patients with histologically or cytologically confirmed unresectable stage III NSCLC, without sensitising mutations, and Eastern Cooperative Oncology Group(ECOG) performance status 0–1. Patients will receive two cycles of induction sintilimab (200 mg, day 1, every 3 weeks) plus platinum-based doublet chemotherapy, followed by definitive cCRT with adaptive radiotherapy planning strictly limiting both lung V20 ≤20%. Radiotherapy dose can be delivered in three optional regimens based on tumour volume and distribution: (1) planning gross tumour volume (PGTV) 60–66 Gy/2.0–2.2 Gy/30F with planning target volume (PTV) 54 Gy/1.8 Gy/30F; (2) PGTV 54–66 Gy/2.0–2.2 Gy/30F without PTV irradiation or (3) PGTV 50 Gy/2.0 Gy/25F without PTV irradiation. During radiotherapy, patients will receive two additional cycles of sintilimab plus chemotherapy. Consolidation sintilimab will continue for up to 1 year or until disease progression/unacceptable toxicity.
Ethics and dissemination
This study was approved by the Institutional Ethics Committee of The Third Xiangya Hospital, Central South University (approval number: R25063; the approval letter is provided as online supplemental file 1). The study results will be disseminated through publication in peer-reviewed journals, presentations at national and international scientific conferences and communication to participants and the public via institutional channels and patient advocacy groups. Individual participant data will be available on reasonable request after study completion, subject to institutional and ethical approvals.
Trial registration number