Efficacy and Safety of Camrelizumab (SHR-1210) With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer: a Single-Arm, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- Major Pathological Response (MPR) Rate
研究概览
简要总结
This trial will evaluate the safety and efficacy of Camrelizumab (SHR-1210) in combination with apatinib neoadjuvant therapy before surgery [neoadjuvant phase], followed by camrelizumab alone after surgery [adjuvant phase] in participants with resectable stage IIA-IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC).
详细描述
This trial will evaluate the safety and efficacy of camrelizumab in combination with apatinib neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by camrelizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant camrelizumab in combination with apatinib, followed by surgery and adjuvant camrelizumab will improve: 1)MPR assessed by investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) ; 2) event free survival (EFS) and 3) overall survival (DFS).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 -70 years, male and female are not limited;
- •Patients with ECOG score of 0-1;
- •The thoracic surgeon judges the patients without contraindications;
- •Patients with early stage non-small cell lung cancer confirmed by histopathology; patients with stage iia-iiib non-small cell lung cancer (IIIB only limited to T3N2), which can be resected radically (according to the 8th edition of the International Association for lung cancer research (IASLC) breast cancer staging manual);
- •Patients with sufficient lung function;
- •Patients who need to obtain tumor tissue for EGFR mutation detection before operation, and no sensitive mutation was found in the EGFR detection results;
- •Patients with measurable target lesions according to the RECIST 1.1 standard;
- •Patients who have not received anti-tumor treatment for NSCLC;
- •Patients with normal function of main organs;
- •The fertile female patients must carry out the serum pregnancy test within 72 hours before the first medication, and the result is negative. The fertile female subjects and the male subjects whose partners are fertile females must agree to use efficient methods of contraception and lactation during the study period and within 90 days after the last administration of the study drug.
排除标准
- •Patients with tumor metastasis and known EGFR driving gene mutation;
- •Patients who have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, immunotherapy and anti-tumor treatment with traditional Chinese medicine;
- •Imaging (CT or MRI) shows that the tumor invades into the large blood vessels or the border with the blood vessels is unclear; or imaging (CT or MRI) shows that there is any pulmonary cavity or necrotic lesions;
- •Patients with any active autoimmune disease or history of autoimmune disease;
- •Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co infection with hepatitis B and hepatitis C;
- •Patients with uncontrollable third cavity effusion, such as massive pleural effusion or ascites or pericardial effusion;
- •Routine urine test indicated that urine protein was >= (+ +), or 24-hour urine protein was >= 1g, or severe liver and kidney dysfunction;
- •Subjects requiring systemic treatment with corticosteroids (> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
- •Patients with other malignant tumors in the past 5 years;
- •Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
- •Patients with uncontrollable hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite the best drug treatment);
- •Patients with cardiac insufficiency;
- •Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.);
- •Patients who underwent major surgery, open biopsy or significant trauma within 28 days before admission;
- •Patients with hemoptysis, active bleeding, ulcer, intestinal perforation and intestinal obstruction within 3 months before admission;
- •Patients who are taking part in other clinical studies or the time of the first medication is less than 4 weeks from the end of the previous clinical study (the last medication);
- •Patients with severe infection or fever of unknown origin > 38.5 degrees C within 4 weeks before medication;
- •Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures.
研究组 & 干预措施
apatinib+ Neoadjuvant/Adjuvant camrelizumab
Neoadjuvant: Prior to surgery, participants receive 3 cycles (cycle length: 2 weeks) of camrelizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with apatinib ,5 days on 2days off].
Adjuvant: 4-8 weeks following surgery, participants receive up to 12 cycles (cycle length: 2 weeks) of camrelizumab [200 mg, IV; given on cycle day 1]. Participants who can not able to benefit from immunotherapy will not receive camrelizumab adjuvant therapy.
干预措施: SHR-1210 (Drug)
apatinib+ Neoadjuvant/Adjuvant camrelizumab
Neoadjuvant: Prior to surgery, participants receive 3 cycles (cycle length: 2 weeks) of camrelizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with apatinib ,5 days on 2days off].
Adjuvant: 4-8 weeks following surgery, participants receive up to 12 cycles (cycle length: 2 weeks) of camrelizumab [200 mg, IV; given on cycle day 1]. Participants who can not able to benefit from immunotherapy will not receive camrelizumab adjuvant therapy.
干预措施: Apatinib (Drug)
结局指标
主要结局
Major Pathological Response (MPR) Rate
时间窗: Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12)
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
次要结局
- Pathological Complete Response (pCR) Rate(Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12))
- Objective Response (OR)(up to 6 weeks)
- Event Free Survival (EFS)(up to 5 years)
- Disease-Free Survival (DFS)(up to 5 years)
- Adverse Events (AEs)(up to 17 weeks)
研究者
Shugeng Gao
chief physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences