A Phase II, Randomised Study of Toripalimab as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiotherapy

Sun Yat-sen University1 个研究点分布在 1 个国家目标入组 170 人2020年6月1日

适应症Small Cell Lung Cancer Limited Stage

干预措施Toripalimab

概览

阶段: 2 期
干预措施: Toripalimab
疾病 / 适应症: Small Cell Lung Cancer Limited Stage
发起方: Sun Yat-sen University
入组人数: 170
试验地点: 1
主要终点: Progression-free Survival
状态: 终止
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The phase II, randomised study is to explore the efficacy and safety of toripalimab as consolidation therapy in patients with limited-stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy

注册库

clinicaltrials.gov

开始日期

2020年6月1日

结束日期

2024年5月31日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Sun Yat-sen University

责任方

Principal Investigator

主要研究者

Hui Liu

Prof.

Sun Yat-sen University

入排标准

入选标准

•Provision of signed, written and dated informed consent prior to any study specific procedures;
•Male or female aged 18-75 years;
•Histologically- or cytologically-documented SCLC;
•Stage I-III (AJCC/UICC 8th TNM Staging), with all lesions can be included in a tolerable radiotherapy field (limited-stage);
•Previous thoracic radiotherapy (45 Gy twice daily or 60-66 Gy once daily) and concurrent etoposide and platinum for four cycles; Dose coverage ≥ 85% of PTV-GTV. Radiotherapy started before the completion of the third cycle of chemotherapy;
•CR, PR or SD after concurrent chemoradiotherapy (RECIST v1.1);
•PCI is allowed and should be completed within 90 days after the completion of chemoradiotherapy;
•Randommization shoud be completed within 90 days after the completion of chemoradiotherapy;
•Life expectancy ≥12 weeks;
•World Health Organization (WHO) Performance Status of 0 or 1;

排除标准

•Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study;
•Mixed small cell and non-small cell lung cancer histology;
•Extensive-stage SCLC;
•Histologically-confirmed malignant pleural or pericardial effusion;
•Sequential chemoradiotherapy, or radiotherapy did not start before the completion of the third cycle of chemotherapy;
•Progressive disease after concurrent chemoradiotherapy (RECIST v1.1) and before randomization;
•Prior use of surgery, radiotherapy or chemotherapy for SCLC, with the exceptions of thoracic concurrent chemoradiotherapy and PCI;
•Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy will be excluded from randomization;
•Patients with Grade ≥2 pneumonitis from prior chemoradiation therapy will be excluded from randomization;
•Current or prior use of immunosuppressive medication within 28 days before the first dose of toripalimab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the previous chemoradiotherapy for SCLC is allowed;