NCT04124731Unknown2 期
SUNRISE: A Phase II Randomized Control Study of Sintilimab Combined With Anlotinib Versus Standard Platinum-based Chemotherapy as a First-line Treatment in Patients With Advanced NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 98
- 主要终点
- Objective Respond Rate (ORR)
研究概览
简要总结
This is an open label, multi-center, randomized control phase II trial, to compare the efficacy and safety of sintilimab combined with anlotinib versus standard platinum-based chemotherapy as a first-line treatment in advanced NSCLC patients without driven-gene mutations.
详细描述
This is an open label, multi-center, randomized control study comparing the combination of sintilimab and anlotinib with standard platinum-based chemotherapy in treat-naïve advanced (unresectable stage IIIB, IIIC and IV patients without driven-gene mutations) NSCLC patients. Eligible subjects are 1:1 randomized into the experimental group (sintilimab combined with anlotinib) or the control group (standard platinum-based chemotherapy).
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
- 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
- •Signed written informed consent before initiation of any study procedures
- •Age ≥ 18 years and ≤ 75 years
- •Histologically or cytologically confirmed NSCLC, with unresectable local advanced or metastatic disease (stage IIIB-IV according to NSCLC staging version 8)
- •Epidermal Growth Factor Receptor (EGFR)/ Anaplastic Lymphoma Kinase (ALK) wild type non-small cell lung cancer
- •Sufficient qualified tumor tissue or Paraffin-embedded slides are provided to detect the expression of PD-L1 (TPS, 22C3 antibody).
- •At least 1 measurable disease according toRECIST 1.1
- •None previous chemotherapy or targeted therapy. Adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment
- •Expected survival over 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Brain metastasis patients with no symptoms or stable symptoms after local treatment are eligible, provided they meet all of the following conditions:
- •measurable lesions outside the central nervous system 2) no central nervous system symptoms or no aggravation of symptoms for at least 2 weeks 3) patients who did not require glucocorticoid therapy or who discontinued glucocorticoid therapy within 3 days before the first study drug administration
- •Patients are allowed to receive palliative radiotherapy (including craniocerebral radiotherapy for symptomatic brain metastases) at least 1 week prior to enrollment and return to less than or equal to 1 degree of radiosurgery toxicity (CTCAE 5.0, excluding alopecia).
- •Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to randomization:
- •For female patients of childbearing age, a urine or serum pregnancy test should be administered within 3 days prior to the first study drug administration (day 1 of cycle 1) and results should be negative. If a urine pregnancy test does not confirm a negative result, a blood pregnancy test is required. Non-childbearing female were defined as those who had been postmenopausal for at least 1 year or who had undergone surgical sterilization or hysterectomy.
- •If pregnancy is potential, all patients (male and female) are required to use contraception with an annual failure rate of less than 1% for the entire treatment period up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
排除标准
- •Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung cancer (including small cell cancer and non-small cell mixed lung cancer).
- •Patients with cavernous squamous cell carcinoma or imaging suggesting infiltration/invasion of large blood vessels or other high bleeding risk factors evaluated by the investigators.
- •Active hemoptysis within 2 weeks before first drug administration (at least 1/2 teaspoon blood spilt at one time);
- •Received radiotherapy before administration of the first study drug, which met one of the following conditions:
- •≥30% of bone marrow had received radiotherapy within 14 days before treatment 2) received radiotherapy for lung lesions within 6 weeks before treatment with >30Gy dose (enrolled subjects must recover from the toxicity of previous radiotherapy to level 1 or below, do not need glucocorticoid treatment and have no history of radiation pneumonia) 3) the end time of palliative radiotherapy should be within 7 days before the first study drug administration
- •Major surgical treatment within 3 weeks of the first study drug administration (except for biopsy surgery)
- •Have Participated in other clinical studies or less than 4 weeks before the end of treatment in the previous clinical study
- •Previously diagnosis as other malignant tumors within 5 years prior to the first dose of study treatment, with the exception of: skin basal cell carcinoma or squamous cell carcinoma with radical treatment, and/or carcinoma in situ underwent radical resection
- •Prior treatment with PD-1 inhibitor, PD-L1 inhibitor, CTLA4 inhibitor, or anti- angiogenic treatment.
- •A history of active autoimmune disease requiring systemic treatment (e.g. using drugs for disease remission, corticosteroids or immunosuppressor) within 2 years prior to the first dose of study treatment. Substitution therapy (e.g. thyroxine, insulin or physiological corticosteroids for treating adrenal or pituitary dysfunction) is not considered as a systemic treatment.
- •Received a traditional Chinese medicine with anti-tumor effect, or an immunomodulatory drug (thymosin, interferon, interleukin) within 2 weeks before the first dose, or received major surgery within 3 weeks before the first dose
- •Systemic steroid therapy or any other form of immunosuppressive therapy performed within 7 days prior to the first dose of study (physiologic dose is allowed).
- •The presence of clinically uncontrollable pleural effusion/peritoneal effusion
- •Have received a physical organ or blood system transplant
- •allergic to the active ingredients or excipients of the drugs studied, such as sintilimab, pemetrexed, gemcitabine, carboplatin, cisplatin, etc.
- •Patients with multiple factors that affect oral medications (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction)
- •Patients with bleeding tendencies (such as active gastrointestinal ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; Small doses of warfarin (≤1mg/d), small doses of heparin (≤ 12,000 U/d) or small doses of aspirin (≤100mg/d) are allowed for prophylactic purposes, provided that the international standardized ratio of prothrombin time (INR) ≤1.5
- •Patients with severe arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, which occurred within 6 months before the first treatment
- •Not fully recovered from toxicity and/or complications resulting from any intervention prior to initiation of treatment (i.e., ≤1 or baseline, excluding fatigue or hair loss);
- •A history of human immunodeficiency virus (HIV) infection (ie, HIV 1/2 antibody positive) is known.
- •Untreated active hepatitis B;
- •Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection)
- •Vaccination of live vaccine within 30 days before the first dose (1st cycle, 1st day);
- •Pregnant or lactating women
- •Any serious or uncontrolled systemic diseases
- •Any medical history or evidence of disease that may interfere with the outcome of the study, or other conditions that the investigator considers inappropriate for the study.
研究组 & 干预措施
Sintilimab plus anlotinib
Experimental
Sintilimab and anlotinib combination therapy
干预措施: sintilimab plus anlotinib (Drug)
Control
Active Comparator
Standard platinum-based chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Objective Respond Rate (ORR)
时间窗: up to 24 months after enrollment or study close
ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).
次要结局
- Disease Control Rate (DCR)(up to 24 months after enrollment or study close)
- Progression Free Survival (PFS)(up to 24 months after enrollment or study close)
- Duration of Response (DoR)(up to 24 months after enrollment or study close)
- Overall Survival (OS)(up to 24 months after enrollment or study close)
研究者
Baohui Han
Professor, Director of Pulmonary Medicine at Shanghai Chest Hospita
Shanghai Chest Hospital
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