A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer
NCT ID: NCT05318443
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
512 participants
INTERVENTIONAL
2020-04-17
2023-01-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental
SIBP04 \& Paclitaxel \& Carboplatin
SIBP04
SIBP04, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.
Paclitaxel
Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.
Carboplatin
Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.
Control group
Avastin \& Paclitaxel \& Carboplatin
Avastin
Avastin, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.
Paclitaxel
Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.
Carboplatin
Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.
Interventions
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SIBP04
SIBP04, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.
Avastin
Avastin, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.
Paclitaxel
Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.
Carboplatin
Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.
Eligibility Criteria
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Inclusion Criteria
* Age≥18 years old and≤75 years old (subject to the date of signing the informed consent form), male or female;
* Non-squamous non-small cell lung cancer confirmed by histology or cytology (excluding sputum cytology), and according to the International Association for the Study of Lung Cancer (IASLC) eighth edition staging criteria, evaluated as stage IIIB-IV inoperable treatment or locally advanced, recurrent or metastatic subjects who cannot receive radical radiotherapy or refuse radical radiotherapy; if there are multiple tumor components, they should be classified according to their main cell types;
* EGFR, ALK, ROS-1 positive patients can be enrolled voluntarily, and the subjects need to provide the test results report of the above genes (If the subject fails to provide the EGFR, ALK, ROS-1 gene test report, he or she must provide tissue sections or tumor specimens for testing in this research center or a tertiary hospital. When the driver gene is unknown, the investigator and the subject jointly decide whether to join the group);
* At least one evaluable target lesion confirmed by imaging (evaluated according to RECIST 1.1 criteria);
* ECOG PS score is 0-1;
* Expected survival time ≥ 6 months;
* No systematic anti-tumor treatment for locally advanced or metastatic non-squamous non-small cell lung cancer \[Subjects can be enrolled if they receive adjuvant therapy after completing curative treatment for early-stage non-small cell lung cancer, but have disease recurrence. In this case, the end time of adjuvant therapy is required to be more than 6 months after the first administration of this study, and the various toxic reactions caused by adjuvant therapy have recovered (judged by CTCAE 5.0 standard ≤ grade 1, except for alopecia ) or a new lesion appeared 6 months after the end of radical radiotherapy in stage IIIB patients\]
* Laboratory results at screening:
Blood routine: white blood cell count≥3.5×109/L, absolute value of neutrophil ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥100g/L; Liver function: total bilirubin ≤1.5× upper limit of normal (ULN); subjects without liver metastases had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; liver Metastatic subjects with ALT and AST ≤ 5×ULN; Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥ 55mL/min, and urine routine test results show urine protein \<2+, for subjects whose urine routine test shows urine protein ≥2+ at baseline, 24 hours urine collection should be performed and protein content in urine \<1.0g within 24 hours; Coagulation function: International Normalized Ratio (INR) ≤1.5, and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;
* Female subjects of childbearing age, male subjects and male subjects' partners agree to use reliable contraceptive measures from the time of signing the informed consent to 6 months after the end of the last trial drug infusion (such as abstinence, or physical contraception, or hormonal contraception, etc.);
* Subjects need to communicate well with the investigator, and be able to follow the visit, treatment, laboratory examination and other relevant regulations.
Exclusion Criteria
* Malignant tumors other than lung cancer within 5 years, excluding cured cervical carcinoma in situ, skin basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and breast ductal carcinoma in situ after radical resection, etc. ;
* Left ventricular ejection fraction (LVEF) \< 50% by color Doppler echocardiography;
* Imaging examination at the screening stage show that the tumor approaches, surrounds, or invades the lumen of a large vessel (eg, the pulmonary artery or superior vena cava);
* Subjects with high suspicion of idiopathic pulmonary fibrosis, organizing pneumonia, drug-related pneumonia, idiopathic pneumonia, active pneumonia or active pulmonary tuberculosis by chest imaging examination during the screening stage;
* Previous history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension (systolic blood pressure\>150mmHg, and/or diastolic blood pressure\>100mmHg);
* Any unstable systemic disease within 6 months prior to randomization: Including but not limited to cerebrovascular accident or transient ischemic attack, unstable angina pectoris, myocardial infarction, congestive heart failure \[New York Heart Association (NYHA) grade ≥ grade II\], severe arrhythmia requiring drug treatment, etc.;
* There are serious unhealed wounds or fractures, or major surgery (including thoracotomy, or major surgery is expected during the study period) within 28 days before randomization; For major surgery, refer to the 3rd and 4th grade surgery stipulated in the "Administrative Measures for the Classification of Surgery in Medical Institutions (Trial)";
* Subjects who have undergone minor surgery within 48 hours before randomization, and who are judged by the investigator to have a bleeding tendency;
* Subjects who have a history of chest radiotherapy within 28 days before randomization, or those who have received palliative radiotherapy for bone metastases within 14 days before randomization;
* History of the following within 6 months before randomization: peptic ulcer, gastrointestinal perforation, erosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, or intra-abdominal abscess;
* Definite diagnosis of tracheoesophageal fistula;
* Bleeding tendency, high bleeding risk, or coagulation disorder, including history of hemoptysis within 3 months before screening (single hemoptysis ≥ 2.5 ml bright red blood),or recently (≤10 days from first dose of study drug) full-dose oral or parenteral anticoagulants or thrombolytics or aspirin (\>325 mg/day) or other non-steroidal anti-inflammatory drugs that inhibit platelet function; or have undergone surgery before, and the investigator judges that they have bleeding tendency;
* Subjects with known central nervous system metastases (except for the subjects with asymptomatic brain metastases and whose symptoms were controlled after treatment and stable within 1 month before randomization);
* Serious infection (including but not limited to infection requiring hospitalization, bacteremia, severe pneumonia, etc.) occurred within 28 days before randomization;
* A history of vascular disease requiring surgical repair within 6 months prior to randomization, such as aortic aneurysm or arterial thrombosis;
* Known to be allergic to SIBP04, Avastin®, Paclitaxel, Carboplatin injection or their excipients;
* Known history of autoimmune disease, allergic disease or allergic constitution (allergic to two or more foods and drugs);
* Received any other experimental drug treatment or participated in another interventional clinical trial within 3 months before screening;
* In the screening stage, Hepatitis B surface antigen was positive, and the level of hepatitis B virus DNA (HBV-DNA) in peripheral blood was higher than the reference value or lower limit of detection method; Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody test was positive;
* Pregnant or lactating women or women preparing to be pregnant or lactating during the study period, or with a positive pregnancy test result at screening stage or baseline;
* Uncontrollable pericardial effusion, abdominal cavity, pleural effusion and other third space effusion within 14 days before randomization, and the investigator judges that they are not suitable for this study;
* Other circumstances determined by the investigator as unsuitable for participation in this study.
18 Years
75 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Shanghai Institute Of Biological Products
INDUSTRY
Responsible Party
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Principal Investigators
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Yuankai Shi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Aidong Qu, Master
Role: STUDY_DIRECTOR
Co., Ltd Shanghai Institute Of Biological Products
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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References
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Shi Y, Bi M, Li Q, Wang G, Chen J, Li M, Shi J, Mei J, Ji Y, Xia Q, Feng Y, Xu S, Zhang T, Gao X, Tang S, Weng J, Cao Z, Wu H, Ren X, Xie H, Liu H, Liu Q, Yin X, Luo X, Chen J, Zhang H, Guo Z, Ding C, Jin X, Sun R, Yang S. Efficacy and safety of bevacizumab biosimilar SIBP04 compared with bevacizumab (Avastin(R)) as first-line treatment for locally advanced or metastatic non-squamous non-small-cell lung cancer: A randomized, double-blind, phase 3 trial. Cancer Pathog Ther. 2025 Jan 6;3(4):337-345. doi: 10.1016/j.cpt.2025.01.001. eCollection 2025 Jul.
Qu A, Zhang S, Zou H, Li S, Chen D, Zhang Y, Li S, Zhang H, Yang J, Yang Y, Huang Y, Li X, Zhang Y. Outcome benefits of bevacizumab biosimilar (SIBP04) combined with carboplatin and paclitaxel in advanced non-squamous non-small-cell lung cancer patients with EGFR mutation: subgroup analysis of a prospective, randomized phase III clinical trial. J Cancer Res Clin Oncol. 2023 Nov;149(14):12713-12721. doi: 10.1007/s00432-023-05103-4. Epub 2023 Jul 15.
Other Identifiers
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SIBP04-02
Identifier Type: -
Identifier Source: org_study_id