2023-507097-41-01
招募中
3 期
A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy
Shanghai Junshi Biosciences Co. Ltd.66 个研究点 分布在 8 个国家目标入组 149 人开始时间: 2025年2月10日最近更新:
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Shanghai Junshi Biosciences Co. Ltd.
- 入组人数
- 149
- 试验地点
- 66
- 主要终点
- OS
概览
简要总结
To compare and evaluate the efficacy of tifcemalimab combined with toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by overall survival (OS) and Blinded Independent Review Committee (BIRC)-assessed progression-free survival (PFS)
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized, double-blind, placebo-controlled
- 盲法
- Double (Analyst, Carer, Investigator, Monitor, Subject)
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
- 是
入选标准
- •Male or female with age ≥ 18 years old at the time of informed consent.
- •Female patients of childbearing potential and male patients whose partners are women of childbearing age are required to use a medically approved form of highly effective methods of contraception (e.g., intrauterine device, birth control pill, or condom with spermicide) during study treatment and at least 4 months after the last dose of tifcemalimab/placebo or toripalimab/placebo
- •Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures
- •Histologically / cytologically confirmed limited-stage (Tumor Node Metastasis [TNM] Stage I-III [T any, N any, M0] by AJCC eighth edition) SCLC that can be safely treated with definitive radiation doses. Patients with Stage I or II disease must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery.
- •Received concurrent CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-70 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy or radiotherapy (whichever occurs last).
- •Patients must achieve a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed PD prior to study entry
- •Prophylactic cranial irradiation (PCI) is permitted per Investigator’s discretion and local standard of care. PCI can be done prior to study entry or during the treatment period.
- •Approximately 5 unstained formalin-fixed, paraffin-embedded serial slides from archival or recently obtained tumour tissue prior to radiotherapy (preferably recently obtained tissues) should be provided for biomarker analysis. Patients who cannot provide adequate tumour tissue samples as described above can only be enrolled after discussion and agreement between the Investigator and the Sponsor.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1
- •Life expectancy ≥ 12 weeks.
排除标准
- •Mixed SCLC and non-small cell lung cancer (NSCLC).
- •History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
- •Patients with active tuberculosis by medical history or computed tomography (CT) examination, those with a history of treated active tuberculosis within 1 year prior to enrolment, or those with a history of untreated active tuberculosis more than 1 year prior to enrolment.
- •The presence of active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method).
- •Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer.
- •Women who are pregnant or breastfeeding.
- •Uncontrolled co-morbidities, including but not limited to symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) < 50%, uncontrolled hypertension, unstable angina, uncontrolled arrhythmias, severe chronic gastrointestinal disease with diarrhoea, or psychiatric/social conditions that may compromise study compliance, result in a significantly increased risk of an AE, or affect the patient's ability to provide written consent.
- •Patients, as determined by the Investigator, who may have other conditions likely to lead to early study withdrawal, such as other serious diseases (including psychiatric disease) requiring concomitant therapy, prisoners, participants who are involuntarily incarcerated or are expected to perform mandatory military service in the coming years, serious laboratory abnormalities, and/or family or social factors that may compromise patient safety or information collection.
- •Individuals who are dependent on the Sponsor, clinical site, or Investigator (e.g., an employee of the Sponsor or a clinical trial site, a dependent of the Investigator, or any site staff members otherwise supervised by the Investigator).
- •Individuals who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, in accordance with local regulations.
结局指标
主要结局
OS
OS
BIRC-assessed PFS (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1).
BIRC-assessed PFS (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1).
次要结局
- Investigator-assessed PFS
- 1-year and 2-year OS rates
- - Investigator-assessed ORR - Investigator-assessed DCR. - Investigator-assessed DoR.
- - Safety: incidence of AEs, abnormal laboratory parameters. - PK of tifcemalimab and toripalimab: trough concentrations. - Immunogenicity of tifcemalimab and of toripalimab: incidence and titers of anti-drug antibodies (ADAs) and, if ADA positive, neutralizing antibodies (NAbs).
研究者
Minjie Shen
Scientific
Shanghai Junshi Biosciences Co. Ltd.
研究点 (66)
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