The Efficacy and Safety of Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume (Bulky) Local Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is a Phase II study to evaluate the clinical efficacy and safety of Toripalimab combined with chemoradiotherapy for large-volume local advanced non-small cell lung cancer
详细描述
This study is a Phase II study to evaluate the clinical efficacy and safety of two cycles of induction Toripalimab plus chemotherapy followed by definitive chemoradiotherapy and consolidation Toripalimab therapy for large-volume, unresectable, locally advanced stage II-III non-small cell lung cancer ("large volume" is defined as primary tumor ≥5 cm in greatest dimension or metastatic lymph nodes ≥2 cm in shortest diameter).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years; ECOG score 0-
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- •Unresectable Stage II-III NSCLC (according to AJCC 8th edition) with maximum tumor diameter T ≥ 5 cm in the primary tumor or minimum diameter N ≥ 2 cm in mediastinal metastatic lymph nodes.
- •No other previous anti-tumor history, at least 3 months of expected survival.
- •No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.
排除标准
- •Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
- •Patients with other active malignancies within 5 years or at the same time.
- •Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis [except diverticular disease], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).
- •History of allogeneic organ transplantation.
- •History of active primary immunodeficiency.
- •Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness.
- •Women of child-bearing potential who are pregnant or breastfeeding.
- •Allergic to research drug ingredients.
- •Ongoing or prior use of immunosuppressive agents within 14 days prior to first dose
- •The investigator judged other situations not suitable for inclusion in this study.
研究组 & 干预措施
Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy
Participants will receive 2 cycles of induction therapy of platinum-based chemotherapy combined with Toripalimab, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.
干预措施: Toripalimab (Drug)
Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy
Participants will receive 2 cycles of induction therapy of platinum-based chemotherapy combined with Toripalimab, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.
干预措施: Concurrent chemoradiation therapy and consolidation immunotherapy (Radiation)
Induction chemotherapy followed by concurrent chemoradiotherapy
Participants will receive 2 cycles of induction platinum-based chemotherapy, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.
干预措施: Concurrent chemoradiation therapy and consolidation immunotherapy (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Defined as the time from date of recruitment until the date of first documented progression or date of death from any cause, whichever came first.
次要结局
- Overall survival (OS）(From recruitment to the date of any documented death due to any cause, assessed up to 36 months.)
- Adverse Event(AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug, up to 36 months.)
- Disease control rate（DCR）(Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause, assessed up to 36 months.)
- Objective Tumour Response (ORR)(Tumor assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from recruitment until objective progression or death from any cause, assessed up to 36 months.)