Patient recruitment: Randomized, double-blind, controlled, multi-center clinical studies of patients treated with carellidocy monoantigen or placebo and chemotherapy for non-small cell lung cancer

First, the title and background information registration number CTR20202571 related registration number drug name injection with Karelliju monoantitor once used name: drug type biological products clinical application acceptance number enterprises choose not to disclose the adaptive non-small cell lung cancer test professional topic Karelliju single anti-combination famini or placebo and chemotherapy treatment of non-small cell lung cancer patients random, Double-blind, controlled, multi-center clinical research trial popular topic Karelliju single anti-combined famini treatment of non-small cell lung cancer research trial program number SHR-1210-III-324 program latest version number 1.0 version date: 2020-08-13 program is a joint drug is two, Applicant Information Applicant Name 123 Contact Name Yu Suqiang Contact Landline 0518-82342973 Contact Phone Number 15508608847 Contact Emailyusuqiang@hrglobe.cn Contact Postal Address Shanghai-Shanghai - 1288 Haike Road, Pudong New Area, 15th floor contact zip code 201210 III, clinical trial information 1, test purpose evaluation of Karelli pearl single anti-combined apple acid famini capsules with pemetroce and card The non-progressive survival period (progression free survival, PFS)2 of the first-line treatment of advanced or metastasis non-squamous non-small cell lung cancer with the single-anti-combined placebo of carelli beads and carpentry was 2, and the trial design trial classification safety and effectiveness trial phase III design type parallel group randomized randomized blindness double-blind trial ranged from 3 years of age (minimum age) to 70 years of age (maximum age) of male sex Female health subjects were 18-70 years old when they signed the informed consent form, both male and female; 2 histological or cytologically diagnosed non-squamous non-small cell lung cancer (NSCLC) and IIIB-IV Tumors; 3 research centers must be able to provide documentation of subjects' EGFR mutations and APK susceptible conditions, and must be negative; 4 must provide tumor tissue specimens diagnosed with advanced or metastasis tumors (for phase II studies only); 5 Subjects have not previously received systemic chemotherapy for late-stage/metastasis NSCLC; 6 Subjects must have measurable target lesions that pass CT or MRI tests in accordance with RECIST 1.1; 7ECOG PS Scores: 0-1 points; 8 expected survival periods ≥3 months; 9 adequate organ and bone marrow function; 10 female subjects of childbearing age must have a serum pregnancy test 7 days before the first drug use, with negative results. It is also willing to use a medically approved and efficient contraceptive measure (e.g., IDR, contraceptives or condoms) during and within 3 months of the last grant of the study drug;
Excluding non-small cell lung cancer subjects of other pathological histological types of standard 1; 2 cancer meningitis, spinal cord compression, etc.; 3 untreated central nervous system (CNS) tumor metastasis; 4 subjects who can be surgically removed or cured by radiation therapy; 5 Subjects who have been treated with anti-PD-1 (L1) or CTLA4 monoantimmune, VEGF or VEGFR signal path single-target/multi-target inhibitors or monoantigens; Systemic treatment with corticosteroids (10 mg/day of peronissone or equivalent) or other immunosuppressants is required within 14 days of the first dose; 8 Anti-tumor vaccines or other immunostatry drugs with immunostitulation are used within 1 month of the first dose; 9 Anti-tumor Chinese medicine was used within 14 days of the first drug use; 10 are participating in other clinical studies or are taking the first drug for less than 4 weeks from the end of the previous clinical study (last administration) or 5 half-lifes of the drug in the study, whichever is shorter 11 Expect any other form of anti-tumor therapy in the study; 12 persons who under undergo major surgery within 4 weeks of the first dose, non-chest radiation therapists who received 30 Gy within 4 weeks of the first dose, and 24 weeks before the first dose 0 Gy chest radiation, and palliative radiologists who received ≤30 Gy within 2 weeks of the first dose, and failed to recover from the toxicity and/or complications of these interventions to NCI-CTC AE ≤1 degrees (hair loss and subjects with the exception of fatigue; 13 subjects with highly suspected mesothotic pneumonia; or subjects who may interfere with the detection or treatment of suspected drug-related pulmonary toxicity; or other moderate to severe lung diseases that seriously affect lung function; 14 subjects with a history of malignant tumors 15 subjects with severe cardiovascular and cerebrovascular diseases, 16 subjects with high blood pressure who were not well controlled by antihypertensive medication, 17 had clinically significant bleeding symptoms or clear bleeding tendencies in the 3 months before the first drug was used, such as gastrointestinal bleeding, Hemorrhagic stomach ulcers.
Subjects had significant coughing blood, half a teaspoon (2.5 mL) or more per haemorrhage in the first 1 month prior to the first drug; 18 had an act/venous thrombosis event within 6 months prior to the first medication, such as cerebrovascular accidents (including temporary ishemorrhage, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 19 needed to use huafalin or pulmonary embolism; Subjects treated; 20 required long-term antiplate plate plate treatment; 21 tumors had invaded important blood vessels or were determined by the researchers to have a very high risk of attacking important blood vessels during treatment resulting in heavy bleeding; 22 subjects with active tuberculosis (TB); and 23 subjects who had severe infections in the first 4 weeks of treatment, including but not limited to complications of infection, bacterialemia, severe pneumonia, etc., that required hospitalization.
Exclude subjects with CTCAE≥2 active infections that require systematic antibiotic treatment within 2 weeks of the first drug use; 24 subjects who are prepared or have received tissue/organ transplants in the past; and 25 researchers believe may affect oral drug swallowing and digestion Absorption of gastrointestinal diseases or surgical history; 26 subjects who were vaccinated or will be vaccinated alive within 30 days of the first drug use; 27 are not recommended for selection with uncontrolled tumor-related pain; 28 are known to have human immunodeficiency virus (HIV) testing Positive medical history or known to have access to immunodeficiency syndrome (AIDS); 29 active hepatitis B or C patients; 30 subjects with uncontrolled chest fluid, heart build-up fluid, or ascetic fluid that needs to be repeatedly (once a month or more frequently) to lead 31 had severe allergic reactions to other monoclonal antibodies, 32 had allergies or insysions, 33 had a history of severe allergies to pythons, carptonin or their preventive medications, 34 had mental illness, alcoholism, inability to quit smoking, Subjects with conditions such as drug use or substance abuse;35 Subjects who, in the judgment of the researchers, are excluded from any disease, treatment or laboratory abnormality or current evidence that may confuse the results of the study, interfere with the subject's participation in the study procedure, or are not in the best interests of the subject's participation in the study.
4, Trial Group Test Drug Serial Number Name Usage 1 Chinese General Name: Injection with Karelli Pearl Monoanti-English Generic Name: Camrelizumab for Injection Product Name: Erica Dosage Form: Injection Specification: 2 00 mg/branch usage amount: intravenous drip medication time: 2 Chinese common name by scheme: Malitini capsule English generic name: Famitinib malate capsule Product Name: NA Dosage Form: Capsule Dosage: 15mg/granulation Dosage: Oral Medication Time: Use 3 Chinese Common Name by Program: Injection with Pemeser D Sodium English Generic Name: Pemetrexed Disodium for Injection Product Name: Plaid Cymru Le dosage form: injection specification: 500mg/m2 Dosage: Intravenous drip medication time: use 4 Chinese common name according to the scheme: injection with carpentin English generic name: Carboplatin fou Injection product name : Pobei dosage form: injection specification: 0.1g / branch usage: intravenous drip medication time: according to the scheme to use the control drug serial number name usage 1 Chinese general name: injection with Karelli pearl monoanti-English generic name: Camrelizumab for Injection Product Name: Erika Dosage Form: Injection Specification: 200 mg/Branch Usage Dosage: Intravenous Drip Medication Time: Use 2 Chinese Common Name by Program: Malic acid Famini Capsules Placebo English generic name: Falmitinib malate capsule placebo Product Name: NA dosage form: capsule size: 15mg/granulose usage Dosage: Oral medication Time: Use 3 Chinese common name as per plan: Injection with peme cursor Two sodium English generic name: Pemetrexed Disodium for Injection Product Name: Prole dosage form: injection specification: 500mg/m2 Usage Dosage: Intravenous drip medication time: Use 4 Chinese common name by scheme: Carboplatin fou Injection Product Name: Posse Dosage Form: Injection Specification: 0.1g/Branch Dosage: Intravenous Drip Medication Time: Use by Program 5, Main Endpoint Indicator Indicators and evaluation time series indicator evaluation time endpoint indicator selection 1 indicator: pharmacodynamics: serum concentration of Karelli pearl monoanti and plasma concentration and pharmacodynamic parameters (AUC0-t, AUC0-∞ (if applicable), Cmax, Tmax, t1/2z, Vz/F, CL/F); The occurrence rate and severity of the first drug to the last visit to see the safety index 3 indicators: no progress survival (PFS) the first drug to the last visit effectiveness index secondary endpoint indicator and evaluation time series indicator evaluation time endpoint indicator selection 1 indicator; Objective mitigation rate (ORR) first drug use to last visit effectiveness index 2 indicators: mitigation duration (DoR) first drug use to last visit effectiveness index 3 indicators: no progress survival (PFS) first drug use to last visit effectiveness index 4 indicators: total survival (OS) first drug to last visit effectiveness indicator 5 indicators: objective mitigation rate (ORR) Drug use to the last visit effectiveness index 6 indicators: mitigation duration (DoR) first drug use to the last visit effectiveness index 7 indicators: disease control rate (DCR) first drug to the last visit effectiveness index 8 indicators: adverse events (AE) and serious adverse events (SAE) occurrence and severity of the first drug to the last visit safety indicator 9 indicators: relative to the baseline, Anti-Carelli pearl monoantibodies (ADA) and medium antibody (Nab) ratios formed during the study were first drug-to-last-visit safety indicator 10 indicators: biomarkers: PD-L1 expression in tumor tissue specimens first-time drug-to-last-visit effectiveness indicator 6, Data Safety Monitoring Committee (DMC) No 7, for the subject to buy experimental injury insurance has four, researcher information 1, main researcher information 1 name Zhou Cai deposit degree M.D. title physician phone 021-65115006Emailcaicunzhoudr@163.com postal address Shanghai-Shanghai-Zhengmin Road 507 ZIP Code 200433 unit name Shanghai Lung Hospital 2, The main researchers of the information serial number institutions of each participating institution are Zhou Caixuan of Shanghai Lung Hospital in Shanghai, China Shanghai 2 Shanghai Jiaozhou University School of Medicine affiliated Ruijin Hospital, Shanghai, China Shanghai 3 Shanghai Yangpu District Central Hospital Zheng Cui-man, Shanghai, China Shanghai 4 Shanghai University of Traditional Chinese Medicine affiliated Longhua Hospital Li He Root Shanghai, China 5 Zhejiang Cancer Hospital Fan Yun, Zhejiang Province, Hangzhou City, China 6 Zhejiang University Affiliated Second Hospital Li Wei, Hangzhou City, Zhejiang Province, China 7 Zhejiang University Yifu Hospital Fang Yong, Hangzhou City, Zhejiang Province, 8 Zhejiang Province Taizhou Hospital Lu Dongqing, Taizhou City, Zhejiang Province, China, 9 Southeast University Affiliated Zhongda Hospital Zhang Ruifeng, Nanjing City, Jiangsu Province, China 1 0 Huai'an City First People's Hospital Meng Self-Help China Huai'an City 11 Subei People's Hospital Xu Xingxiang China Yangzhou City, Jiangsu Province, China 12 Anhui Medical University First Affiliated Hospital Gu Kangsheng China Anhui Hefei City 13 Anhui Medical University Second Affiliated Hospital Zhao Hui China Anhui Province Hefei City 14 Pan Yueyin, Anhui Provincial Hospital 15 Beijing Concord Hospital, Hefei, Anhui Province, China Beijing 16 Peking University Oncology Hospital Chest Department Zhao Jun Beijing Beijing 17 Peking University Cancer Hospital Chest 2 Fangjian Beijing 18 Chinese Academy of Medical Sciences Cancer Hospital Hu Xingsheng North Beijing, China Beijing 19 Capital Medical University affiliated With Beijing Chest Hospital Li Baolan, Beijing, China 20 Chinese People's Liberation Army General Hospital Ma Junxun, Beijing, China Beijing 21 Tianjin Cancer Hospital Ren Xiubao, Tianjin City, China Tianjin 22 Harbin Medical University Affiliated Oncology Hospital Liu Baogang, Harbin City, Heilongjiang Province, China 23 Jilin Province Cancer Hospital Cheng Ying, 24 China Medical University, Changchun City, China Liu Yunpeng, 25 Shengjing Hospital, Shenyang, Liaoning Province, China, Shengjing Hospital Wu Rong, 26 Dalian Medical University, Shenyang, Liaoning Province, China, 26 Dalian Medical University Affiliated Second Hospital Dai Zhaoxia, Dalian, Liaoning Province, China, 27 Inner Mongolia Medical University Affiliated Hospital Gao Junzhen 28 Chifeng City Hospital Ji Hongbo, Chifeng City, Inner Mongolia Autonomous Region, China 29 Hebei Medical University Fourth Hospital Ding Cuimin, 30 Yantai City People's Hospital, Shijiazhuang City, Hebei Province, China Guo Jun, 31 Shanxi Provincial Cancer Hospital Yang Weihua, Taiyuan City, Shanxi Province, China 32 Shanxi Baithun Hospital Liu Xiansheng, 33 Changzhi City People's Hospital, Taiyuan City, Shanxi Province, China Zhao Xianping, 34 Shandong Province Cancer Hospital Liu Zhifang, 35 Jinan City Center Hospital, Jinan City, Shandong Province, China, Jinan City, China 36 Qingdao City Center Hospital Ma Xuezhen, Qingdao City, Shandong Province, China 37 Henan Province Cancer Hospital Zhao Yan Autumn 38 Zhengzhou City Center Hospital, Zhengzhou City, Henan Province, China Zhengzhou City, 39 Henan University of Science and Technology First Affiliated Hospital Sun Jiangtao, Luoyang City, Henan Province, China 40 Xi'an Jiaozhou University Medical College First Affiliated Hospital Li Manxiang, Xi'an City, Shaanxi Province, China 41 Xi'an Jiaozhou University Medical College Second Affiliated Hospital Yang Shuying Liu Chunling, an oncology hospital affiliated with 42 Xinjiang Medical University in Xi'an, Shaanxi Province, China, and Ma Daiyuan, an affiliated hospital of 45 Sichuan North Medical College in Chengdu, Sichuan Province, China