3763 - Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma (NOTABLE-306): A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
Presenter(s)
S. Wei1, X. F. Li2, L. Zi3, L. Wei4, L. Zou5, Y. Zhang6, X. Sun7, Y. Gao8, Y. Zhuo9, M. Zhang10, A. Qu1, P. Jiang1, and J. Wang1; 1Department of Radiation Oncology, Peking University Third Hospital, Beijing, China, 2Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China, 3The First Affliated Hospital of Xi'an Jiaotong University, Xi'an, China, 4Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University, Xi'an, China, 5Department of Radiation Oncology, The Second Hospital of Dalian Medical University, Dalian, China, 6Department of Radiation Oncology, Harbin Medical University Cancer Hospital, Harbin, China, 7Department of Radiation Oncology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China, 8Liaoning Cancer Hospital, Shenyang, China, 9Department of Radiation Oncology, Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou, China, 10Department of Radiation Oncology, Peking University Peolple's Hospital, Beijing, China
Purpose/Objective(s):
The current standard for treating locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy (CCRT). Overexpression of the epidermal growth factor receptor (EGFR) has been linked to reduced responsiveness to CCRT and poorer outcomes. Therefore, targeting EGFR represents a promising therapeutic approach in cervical cancer. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab concurrent with and following CCRT vs. CCRT alone in patients with locally advanced cervical squamous carcinoma. Adding nimotuzumab to CCRT will enhance progression-free survival (PFS) in patients with International Federation of Gynecology and Obstetrics (FIGO) 2018 stages IB3 to IVA cervical squamous carcinoma, compared to CCRT alone.Materials/Methods:
The NOTABLE-306 trial comprises a phase Ib dose-escalation stage (3+3 design) to determine the optimal nimotuzumab dose, followed by a phase III randomized, multicenter, double-blind, placebo-controlled stage. Patients will be randomized 1:1 to receive weekly nimotuzumab or placebo for 8 cycles, followed by biweekly maintenance for 24 weeks. All participants will undergo external beam radiotherapy (EBRT, 45–50 Gy in 25 fractions) with cisplatin (40 mg/m2, weekly) for 5 weeks, followed by image-guided brachytherapy. Eligible patients are treatment-naïve females aged 18–80 with histologically confirmed cervical squamous carcinoma (FIGO 2018 stages IB3–IVA) and no prior definitive treatments. The primary endpoints include dose-limiting toxicity in phase Ib and PFS in phase III, which were assessed by an independent review using Response Evaluation Criteria in Solid Tumors v1.1 criteria. Stage I includes up to 26 patients to determine dosing. Stage II will enroll approximately 460 patients randomized 1:1 to receive either nimotuzumab or placebo with and following CCRT. Patient enrollment was started in April 2024 with an estimated completion date of April 2030. Trial Registration ClinicalTrials.gov Identifier: NCT06333821Results:
Not applicableConclusion:
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