ArticleJournal of gynecologic oncology2026
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.
Article in Journal of gynecologic oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06333821 (A Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma), which is not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma
Who cites it
1 citing paper in PubMed.
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Authors and funding
15 authors.
Funding
Abstract
backgroundThe 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.
methodsThe 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 registrationClinicalTrials.gov Identifier: NCT06333821.
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