NCT04670913Unknown2 期
A Single-Arm Phase II Trial of Camrelizumab Plus Apatinib for Advanced Non-Squamous NSCLC Previously Treated With First-Line Immunotherapy
Junling Li1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Camrelizumab plus Apatinib in the treatment of advanced non-squamous NSCLC previously treated with first-line immunotherapy
详细描述
This trial will evaluate the safety and efficacy of Camrelizumab plus Apatinib in participants with advanced non-squamous NSCLC previously treated with first-line immunotherapy. The primary objective of this pilot study is to determine the Camrelizumab plus Apatinib improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) duration of response(DoR), 3) overall survival(OS), 4) disease control rate (DCR); the safety and quality of life assessment Explore objective is potential biomarker associated with efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed (infomed consent form, ICF).
- •The best response of first-line immunotherapy was SD or above, and PFS was at least 3 months.
- •Male and female aged ≥18 years and ≤75 years.
- •Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy.
- •Patients who are unwilling to receive chemotherapy after disease recurrence or progression during/after first-line treatment including PD-(L)1 combined with chemotherapy, and PD-(L)1 monotherapy for advanced or metastatic disease.
- •Measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Subjects are eligible if CNS metastases are asymptomatic or treated.
- •Life expectancy ≥12 weeks.
- •Fertile female must agree to use adequate contraception within 24 weeks from the beginning of the first dose of study medication to the last dose.
- •Adequate organ and marrow function.
排除标准
- •Prior treatment with anti-tumor virus, or prior T cell co-stimulation factors,including anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody or other T cell-targeted drugs.
- •Subjects who had discontinued prior treatment due to immune-related adverse events (irAEs) or who are not suitable for PD-(L)1 treatment assessed by the investigator.
- •Subjects with histologically or cytologically-documented squamous cell NSCLC.
- •Prior treatments with anti-angiogenic agents.
- •Subjects with activated EGFR gene mutation or ALK fusion mutation.
- •Untreated or active central nervous system metastases (such as brain or meningeal metastases). Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are off corticosteroids for at least 2 weeks prior to first dose of study therapy.
- •Radiotherapy for the chest and whole brain should be completed within 4 weeks before the first dose of study drug (palliative radiotherapy for bone lesions should be completed before the first dose of study drugs).
- •History of active or recent history of known or suspected autoimmune disease.
- •History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or evidence of active pneumonitis with clinical symptoms.
- •History of active tuberculosis regardless of prior treatment.
- •Malignancies other than NSCLC within 5 years prior to first administration of drugs, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, such as cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection.
- •Known mental illness, alcohol abuse, inability to quit smoking, drug or drug abuse, etc.
- •Active hepatitis B or hepatitis C; History of known HIV-positive history or known AIDS.
- •Treatment with any investigational agent within 28 days of signing ICF.
- •According to the judgment of the investigator, subjects have other factors that may cause the study to be terminated halfway, such as non-compliance with the protocol, other serious diseases (including mental illness) requiring combined treatment, severe laboratory abnormalities, and Factors such as family or society will affect the safety of subjects or the collection of data and samples.
研究组 & 干预措施
Camrelizumab plus Apatinib
Experimental
Camrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po
干预措施: Camrelizumab (Drug)
Camrelizumab plus Apatinib
Experimental
Camrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to 1 year
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
次要结局
- Duration of Response(up to 1 year)
- Overall Survival (OS)(up to 2 years)
- Adverse Events (AEs) and Serious Adverse Events(SAEs)(up to 1 year)
- QLQ-LC13(up to 1 years)
- Objective response rate (ORR)(up to 1 year)
- Disease Control Rate (DCR)(up to 1 year)
- EORTCQLQ-C30(up to 1 years)
研究者
Junling Li
Prof. Junling Li, Chief Physician, Medical Doctor, PhD Tutor, Internal Medicine-Oncology, Chinese Academy of Medical Sciences Cancer Hospital
Peking Union Medical College
研究点 (1)
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