A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- MPR by BIPR
研究概览
简要总结
This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.
详细描述
A total of approximately 390 participants are planned to be enrolled in this study. After being screened and qualified, the subjects will be randomly assigned to receive Envalfolimab or placebo plus platinum-based doublet chemotherapy in 1:1 ratio for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), the feasibility of surgery is evaluated by the investigator within 4-6 weeks after the end of neoadjuvant therapy and surgery will be performed. Envafolimab (experimental group) or placebo (control group) will be administered after surgery. After completion of treatment, subjects will enter a follow-up phase, including safety follow-up, tumor disease follow-up, and survival follow-up.All randomized subjects in this study are required to receive tumor imaging evaluation as scheduled and get continuous safety assessment during the srceening and treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate and sign the informed consent form.
- •Age ≥ 18 years old, regardless of gender.
- •Histological and/or cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC.
- •Measurable lesions based on the response evaluation criteria in solid tumors version 1.1（RECIST 1.1）.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Subjects should provide tumor tissue for detection of PD-L1 expression level.
- •Sufficient organ and bone marrow function.
- •Expected survival ≥6 months.
- •The surgeon assessed that total lung function is able to withstand the proposed pneumonectomy procedure.
排除标准
- •Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types.
- •Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.);
- •Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status;
- •Upper lung sulcus tumor or locally advanced unresectable or metastatic disease.
- •Previous anti-tumor therapy for the disease.
- •Subjects with known or suspected interstitial pneumonia.Radiation pneumonia or other moderate to severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function.
- •Any serious active infection.
- •With uncontrolled or significant cardiovascular and cerebrovascular disease.
- •Active autoimmune disease requiring systemic treatment.
- •Immunosuppressant or systemic hormone therapy (dose >10 mg/ day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.
研究组 & 干预措施
Envalfolimab plus platinum-based doublet chemotherapy
Envalfolimab plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), Envafolimab will be administered after surgery at 600 mg every 3 weeks(Q3W) for 16 cycles at most.
干预措施: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection (Drug)
Placebo plus platinum-based doublet chemotherapy
Placebo plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), placebo will be administered after surgery every 3 weeks(Q3W) for 16 cycles at most.
干预措施: placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection (Drug)
结局指标
主要结局
MPR by BIPR
时间窗: Up to 5 years
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy (evaluated by BIPR)
EFS by BIRC
时间窗: Up to 5 years
EFS is defined as the time from randomization until the occurrence of events leading to inoperable disease progression, post-operative disease progression (BIRC assessment based on RECIST 1.1) or recurrence/metastasis, or death from any cause.
次要结局
- pCR(Up to 5 years)
- PD-L1, ctDNA(Up to 5 years)
- DFS(Up to 5 years)
- EFS(Up to 5 years)
- OS(Up to 5 years)
- Explore the quality of life for subjects by EORTC QLQ-C30(Up to 5 years)
- Explore the quality of life for subjects by EORTC QLQ-LC13(Up to 5 years)