Patient recruitment: Recombinant humanized anti-PD-1 monoclonal antibody (HX008) combined chemotherapy compared to Pabli-Pearl mono-anti-combination chemotherapy as a first-line treatment of advanced or metastasis non-squamous non-small cell lung cancer (NSCLC) phase II/III clinical studies

Basic information registration number CTR20202387 test status in the applicant contact Wang Liyan first public information date 2020-11-26 applicant name Taizhou Han Zhong Biopharmaceutical Co., Ltd. / Hangzhou Hans Biopharmaceutical Co., Ltd. / Zhongshan Kangfang Biopharmaceutical Co., Ltd. announced the test information I, title and background information registration number CTR20202387 related registration number drug name HX008 injection (recombinant human source anti-P injection) D-1 monoclonal antibody) drug type biological products clinical application acceptance number enterprises choose not to disclose the adaptive disease has not received systematic standard treatment of advanced or metastasis non-small cell lung cancer patients test professional topic recombinant humanized anti-PD-1 monoclonal antibody (HX008) combined chemotherapy compared to Pabli bead monoantimmune chemotherapy as a first-line program to treat advanced or metastasis non-small cell lung cancer (NSCLC) II / Phase III clinical research trial popular topic recombinant humanized anti-PD-1 monoclonal antibody (HX008) combined chemotherapy compared to Pabli pearl monoantiba combined chemotherapy as a first-line treatment of advanced or metastasis non-small cell lung cancer (NSCLC) Phase II/III clinical research trial program number HX008-NSCLC-II/III-01 program latest version no. 20-05-26 program is the joint drug is two, the applicant information applicant name 123 contact name Wang Liyan contact landline 010-80123990 contact phone number 15910915260 contact Emailliyan_wang@lepubiopharma.com Main purpose of the trial: to explore the safety and toadability and objective efficiency (ORR) of HX008 combined chemotherapy as a first-line treatment of advanced or metastasis non-small cell lung cancer: 1) To explore HX008 combined chemotherapy as a first-line No progression survival (PFS), remission duration (DOR), 1 year progression-free survival rate, total survival (OS); 2) evaluation of the pharmacodynamics of HX008 And immunogenicity 2, test design test classification safety and effectiveness test phase II design type single-arm trial randomized non-randomized blind method open trial scope domestic trial 3, subject information age 18 years old (minimum age) to no upper limit (maximum age) sex male Female health subjects did not be selected criteria 1 voluntarily signed the informed consent, understand the study and are willing to follow and have the ability to complete all trial procedures 2 men and women, age≥18 years of age 3 histology or cytology diagnosed as phase IV (M1a / b-AJCC 7th Edition) Non-scaly NSCLC 4 for patients with advanced or metastasis NSCLC who have not received systematic treatment 5 patients without EGFR or ALK targeted therapy (no EGFR mutation, ALK gene rearfraction) 6 subjects must have at least 1 measurable lesion (in accordance with THECIST1.1 standard), if the lesions that have previously been treated as lesions must be identified as lesions Disease progression, if there are at least 1 other measurable target lesions, the lesions that have been previously treated as non-target lesions for follow-up 7 random before the need to provide tissue samples to detect PD-L1 expression level 8 estimated survival of at least 3 months 9 Eastern U.S. Tumor Collaboration Group (ECOG) score physical status of 0 or 1 of 10 suitable organ function, according to the following laboratory tests: serum white protein ≥2.5g/dL; An absolute count of neophils (ANC) ≥ 1.5×109/L; Absolute White Blood Cell Count (WBC≥ 3.0×109/L; Plateplate ≥ 100 × 109/L; hemoglobin ≥90g/L, no blood transfusions in the first 4 weeks of group entry; creatinine removal rate (CrCl) ≥50 mL/min; AST and ALT≤2.5x ULN, liver metastasis patients ≤5x ULN; Serum total bililin (TBIL) ≤1.5 times ULAN, in patients with serum total bilirin; 1.5 times ULAN, direct bilium requires ≤ULN; International Standardized Ratio (INR) or Coagulant Time (PT) ≤1.5 times ULN (except for patients undergoing anticoagulant therapy), or infusion of partial coagulant enzymatic enzyme time (AP) TT) or partial clotting bioenzyme time (PTT) ≤1.5 times ULN (except for patients undergoing anticoagulant therapy) 11 Women who are likely to have a pregnancy are required to undergo a urine or serum pregnancy test within 72 hours of the first drug offer, with negative results; Mixed tumor If there is a small cellular component, then the subjects could not be included in group 2 before the first drug was given in this study: a. Systemic cytotoxic chemotherapy or anti-tumor biotherapy for metastatic diseases3 combined with clinically active diverticulitis, abdominal abscesses, gastrointestinal obstruction, peritiotic cancer, active peptic ulcers, gastrointestinal active bleeding, gastrointestinal perforation 4 first-time use of research drugs Patients who have been diagnosed with any other malignancies in the previous 5 years, except those with a low risk of metastasis and death after adequate treatment (5-year survival rate of 90%), such as fully treated substrate or squamous cell skin cancer or cervical disease Bit and other in-place cancers 5 are known to be allergic to any component of large molecular protein preparations/monoclonal antibodies, cisplatin, carpentry or pyrethroids6 have a history of organ transplantation, or stem cell transplant history 7 has received other anti-PD-1, PD-L1 or P D-L2 preparations or antibody therapy for other immunomodulated recipients or mechanisms, including, but not limited to, antibodies against IDO, PD-L1, IL-2R, GITR, or persons who have received Pabliju monoantitherapy 8 Before the first drug was given, severe infections were determined by the researchers to be incompatible with the treatment of patients who participated in the trial 9 unmanageable and stable systemic diseases, such as cardiovascular disease, diabetes, hypertension, etc. 10 have a clear history of neurological or mental disorders, such as epilepsy, dementia, or frequent use of any illicit drugs or (in the last year) ) has a history of substance abuse (including alcohol) that may affect the use of the name of the experimental group test drug serial number 1 Chinese Universal name: HX00 8 Injections (recombinant humanized anti-PD-1 monoclonal antibodies) English generic name: HX008 Commodity Name: NA Dosage form: Injection specification: 10ml:100mg Dosage: Dosage form: HX008 Injection Specification: 100mg/10mL/dose route: intravenous drip frequency: once every three weeks (q3W) dose: 200mg/person/time fixed dose medication time: 45min (±). 15min) The use of the drug serial number name has not yet filled in this information 5, the end point indicator main endpoint indicator and the evaluation time serial number indicator evaluation time end indicator select 1 adverse event; Serial indicator evaluation time endpoint indicator selection 1DCR; DOR; PFS; OS into the group 50% for medium-term analysis, after the test to carry out the overall statistical analysis effectiveness index 6, data safety monitoring committee (DMC) no 7, for the subject to buy test injury insurance has four, researcher information 1, Main Researcher Information 1 Name Zhou Cai deposit degree M.D. Title Director Physician Phone 021-65115006-3051Emailcaicunzhoudr@163.com Postal Address Shanghai-Shanghai-Shanghai-Shanghai Municipal People's Road 507 Shanghai Lung Hospital Oncology Postcode 200433 Unit Name Tongji University Affiliated Shanghai Lung Hospital 2, The main researchers of the information serial number institutions of each participating institution are The main researchers of the National Province (state) City 1 Tongji University affiliated Shanghai Lung Hospital Zhou Caixuan, Shanghai, China 2 Peking University Cancer Hospital Fang Jian, Beijing 3 Hangzhou Cancer Hospital Chen Xueqin, Hangzhou City, Zhejiang Province, China 4 Anhui Provincial Hospital, Hefei City, Anhui Province, China, 5 Central South University Xiangya Hospital Pan Fenghua, Changsha City, Hunan Province, China, 6 Hunan Province Cancer Hospital Third Hospital Cao Baoshan Beijing, China 9 Harbin Medical University affiliated oncology hospital in Harbin City, Heilongjiang Province, China 10 Liaoning Province Cancer Hospital Li Xiaoling, Liaoning Province, China, Shenyang City, the ethics committee information serial number name review conclusion approval date / filing date 1 Shanghai Lung Hospital Ethics Review Committee agreed to 2020-07-24CDE Source: CDE Copyright Statement: All noted on this website "Source: Meis Medicine" or "Source: Meds Medicine" "The copyrights to the text, images and audio-visual materials shall be owned by Metz Medicine and shall not be reproduced by any media, website or individual without authorization, and shall be reproduced with the words "Source: Metz Medicine".
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