2024-520386-31-00招募中3 期
A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma
Johnson & Johnson Enterprise Innovation Inc.54 个研究点 分布在 9 个国家目标入组 193 人开始时间: 2025年6月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 193
- 试验地点
- 54
- 主要终点
- Progression-free survival (PFS): time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first
研究概览
简要总结
To evaluate survival outcomes in subjects treated with intratumorally injected JNJ- 90301900 (NBTXR3) activated by Investigator’s choice of radiotherapy (RT) alone or RT in combination with cetuximab in comparison to Investigator’s choice alone hereafter referred to as JNJ-90301900 (NBTXR3) /RT±cetuximab versus RT±cetuximab
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years old
- •Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
- •Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
- •One primary tumor lesion amendable for intratumoral injection
- •Ineligible to receive platinum-based chemotherapy with radiation: a. Estimated creatinine clearance ≥30 and <50 mL/min (per Cockcroft-Gault equation), Grade ≥2 hearing loss or tinnitus, Grade ≥2 peripheral neuropathy, ECOG Performance Status 2, New York Heart Association Class 3 b. Age 70-74 years old with Geriatric 8 (G8) score ≤ 14 c. Age ≥ 75 years old"
排除标准
- •Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
- •Non-squamous cell histology
- •Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
- •Loco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
- •Prior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
- •Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization
结局指标
主要结局
Progression-free survival (PFS): time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first
Progression-free survival (PFS): time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Johnson & Johnson Enterprise Innovation Inc.
研究点 (54)
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